EBQ:Major Cardiology Trials - Revision history

Ostermayer: Text replacement - "Category:Cards" to "Category:Cardiology"

2016-03-22T13:52:50Z

Text replacement - "Category:Cards" to "Category:Cardiology"

← Older revision		Revision as of 13:52, 22 March 2016
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	==Sources==		==Sources==
	<references/>		<references/>
	[[Category:~~Cards~~]]		[[Category:Cardiology]]

Ostermayer at 04:15, 31 March 2014

2014-03-31T04:15:02Z

← Older revision		Revision as of 04:15, 31 March 2014
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			==Sources==
	<references/>		<references/>
	[[Category:Cards]]		[[Category:Cards]]

Ostermayer: Ostermayer moved page Trials - Cardiology to EBQ:Major Cardiology Trials

2014-03-31T03:30:41Z

Ostermayer moved page Trials - Cardiology to EBQ:Major Cardiology Trials

← Older revision	Revision as of 03:30, 31 March 2014
(No difference)

Ostermayer: /* OASIS-7The CURRENT–OASIS 7 Investigator. Dose Comparisons of Clopidogrel and Aspirin in Acute Coronary Syndromes PDF */

2014-03-31T00:47:15Z

OASIS-7The CURRENT–OASIS 7 Investigator. Dose Comparisons of Clopidogrel and Aspirin in Acute Coronary Syndromes PDF

← Older revision		Revision as of 00:47, 31 March 2014
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	===OASIS-7<ref>The CURRENT–OASIS 7 Investigator. Dose Comparisons of Clopidogrel and Aspirin in Acute Coronary Syndromes [http://www.nejm.org/doi/pdf/10.1056/NEJMoa0909475 PDF]</ref>===		===OASIS-7<ref>The CURRENT–OASIS 7 Investigator. Dose Comparisons of Clopidogrel and Aspirin in Acute Coronary Syndromes [http://www.nejm.org/doi/pdf/10.1056/NEJMoa0909475 PDF]</ref>===
	*Randomized trial of 25,086 patients with an acute coronary syndrome referred for an invasive strategy		*Randomized trial of 25,086 patients with an acute coronary syndrome referred for an invasive strategy
	**Double dose clopidogrel (a 600-mg loading dose on day 1, followed by 150 mg daily for 6 days		**Double dose clopidogrel (a 600-mg loading dose on day 1, followed by 150 mg daily for 6 days and 75 mg daily thereafter)
	and 75 mg daily thereafter)
	**Standard-dose clopidogrel (a 300-mg loading dose and 75 mg daily thereafter)		**Standard-dose clopidogrel (a 300-mg loading dose and 75 mg daily thereafter)
	***Plus either higher-dose aspirin (300 to 325 mg daily) or lower-dose aspirin (75 to 100 mg daily).		***Plus either higher-dose aspirin (300 to 325 mg daily) or lower-dose aspirin (75 to 100 mg daily).
	*No difference between high dose and low dose clopidogrel or asprin.		*No difference between high dose and low dose clopidogrel or asprin.


	===FRISC<ref>Low-molecular-weight heparin during instability in coronary artery disease, Fragmin during Instability in Coronary Artery Disease (FRISC) study group.Lancet. 1996 Mar 2;347(9001):561-8</ref>===		===FRISC<ref>Low-molecular-weight heparin during instability in coronary artery disease, Fragmin during Instability in Coronary Artery Disease (FRISC) study group.Lancet. 1996 Mar 2;347(9001):561-8</ref>===

Ostermayer: /* CURE: Clopidogrel in Unstable Angina to Prevent Recurrent EventsYusuf S, et al. "Effects of Clopidogrel in Addition to Aspirin in Patients with Acute Coronary Syndromes without ST-Segment Elevation". The New England Journal of Medicine. 2001. 345(7)...

2014-03-31T00:46:58Z

/* CURE: Clopidogrel in Unstable Angina to Prevent Recurrent EventsYusuf S, et al. "Effects of Clopidogrel in Addition to Aspirin in Patients with Acute Coronary Syndromes without ST-Segment Elevation". The New England Journal of Medicine. 2001. 345(7)...

← Older revision		Revision as of 00:46, 31 March 2014
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	*No benefit w sulfinpyrazone.		*No benefit w sulfinpyrazone.

	===CURE~~: Clopidogrel in Unstable Angina to Prevent Recurrent Events~~<ref>Yusuf S, et al. "Effects of Clopidogrel in Addition to Aspirin in Patients with Acute Coronary Syndromes without ST-Segment Elevation". The New England Journal of Medicine. 2001. 345(7):494-502[http://www.nejm.org/doi/pdf/10.1056/NEJMoa010746 PDF]</ref>===		===CURE<ref>Yusuf S, et al. "Effects of Clopidogrel in Addition to Aspirin in Patients with Acute Coronary Syndromes without ST-Segment Elevation". The New England Journal of Medicine. 2001. 345(7):494-502[http://www.nejm.org/doi/pdf/10.1056/NEJMoa010746 PDF]</ref>===
	*12,562 pt in Randomized Controlled Trial with Unstale Angina or NSTEMI		*12,562 pt in Randomized Controlled Trial with Unstale Angina or NSTEMI
	*Clopidogrel 300 mg loading dose followed by clopidogrel 75 mg daily for 3 to 12 months.		*Clopidogrel 300 mg loading dose followed by clopidogrel 75 mg daily for 3 to 12 months.
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	*Composite of CV mortality, non-fatal MI, or stroke with 9.3%(clopidogrel) vs 11.5(placebo)		*Composite of CV mortality, non-fatal MI, or stroke with 9.3%(clopidogrel) vs 11.5(placebo)
	*Also less inpatient ischemia & revascularization, less thrombolitic or GP IIb/IIIa administration		*Also less inpatient ischemia & revascularization, less thrombolitic or GP IIb/IIIa administration
	*Increased major and minor bleeding especially in CABG patients.		*Increased major and minor bleeding especially in CABG patients.

	===ESSENCE<ref>Cohen M, et al. "A Comparison of Low-Molecular-Weight Heparin with Unfractionated Heparin for Unstable Coronary Artery Disease". The New England Journal of Medicine. 1997. 337(7):447-452 [http://www.nejm.org/doi/pdf/10.1056/NEJM199708143370702 PDF]</ref>===		===ESSENCE<ref>Cohen M, et al. "A Comparison of Low-Molecular-Weight Heparin with Unfractionated Heparin for Unstable Coronary Artery Disease". The New England Journal of Medicine. 1997. 337(7):447-452 [http://www.nejm.org/doi/pdf/10.1056/NEJM199708143370702 PDF]</ref>===

Ostermayer at 00:46, 31 March 2014

2014-03-31T00:46:31Z

← Older revision		Revision as of 00:46, 31 March 2014
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	* Coumadin & ASA shows no long term benefit		* Coumadin & ASA shows no long term benefit

			===OASIS-2<ref>Effects of recombinant hirudin (lepirudin) compared with heparin on death, myocardial infarction, refractory angina, and revascularisation procedures in patients with acute myocardial ischaemia without ST elevation: a randomised trial. Organisation to Assess Strategies for Ischemic Syndromes (OASIS-2) Investigators. Lancet. 1999 Feb 6;353(9151):429-38</ref>===
			*10,141 patients with unstable angina or suspected acute myocardial infarction without ST elevation
			*Double blind RCT to Heparin (5000 units bolus then 15 units kg) or hirudin (0.4 mg/kg bolus then 0.15 mg kg) for 72 hrs
			*Major bleeding requiring transfusion significantly increased with hirudin

	===OASIS-5 TRIAL<ref>Efficacy and safety of fondaparinux versus enoxaparin in patients with acute coronary syndromes treated with glycoprotein IIb/IIIa inhibitors or thienopyridines: results from the OASIS 5 (Fifth Organization to Assess Strategies in Ischemic Syndromes) trial.J Am Coll Cardiol. 2009 Jul 28;54(5):468-76 [http://www.sciencedirect.com/science/article/pii/S0735109709016015/pdfft?md5=83ac965b2708e83c211a770660723d91&pid=1-s2.0-S0735109709016015-main.pdf PDF]</ref>===		===OASIS-5 TRIAL<ref>Efficacy and safety of fondaparinux versus enoxaparin in patients with acute coronary syndromes treated with glycoprotein IIb/IIIa inhibitors or thienopyridines: results from the OASIS 5 (Fifth Organization to Assess Strategies in Ischemic Syndromes) trial.J Am Coll Cardiol. 2009 Jul 28;54(5):468-76 [http://www.sciencedirect.com/science/article/pii/S0735109709016015/pdfft?md5=83ac965b2708e83c211a770660723d91&pid=1-s2.0-S0735109709016015-main.pdf PDF]</ref>===
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	*n patients receiving GP IIb/IIIa inhibitors or thienopyridines, fondaparinux reduces major bleeding		*n patients receiving GP IIb/IIIa inhibitors or thienopyridines, fondaparinux reduces major bleeding

			===OASIS-6<ref>van Rees Vellinga T. et al. Efficacy and safety of fondaparinux in patients with ST-segment elevation myocardial infarction across the age spectrum. Results from the Organization for the Assessment of Strategies for Ischemic Syndromes 6 (OASIS-6) trial.Am Heart J. 2010 Dec;160(6):1049-55[http://www.emottawa.ca/assets_secure/journal_club/articles/Fondaparinux%20MI_OASIS%20Trial_JAMA_060314.pdf PDF]</ref>===
			*12,092 STEMI patients
			*Primary outcome: Death or recurrent MI
			*Randomization to control of Placebo or UFH based on the investigator's judgment vs fondaparinux
			*Potential morbidity benefit to Fondaparinux in STEMI over UFH in those not undergoing PCI

	OASIS-7<ref>The CURRENT–OASIS 7 Investigator. Dose Comparisons of Clopidogrel and Aspirin in Acute Coronary Syndromes [http://www.nejm.org/doi/pdf/10.1056/NEJMoa0909475 PDF]</ref>		===OASIS-7<ref>The CURRENT–OASIS 7 Investigator. Dose Comparisons of Clopidogrel and Aspirin in Acute Coronary Syndromes [http://www.nejm.org/doi/pdf/10.1056/NEJMoa0909475 PDF]</ref>===
	*Randomized trial of 25,086 patients with an acute coronary syndrome referred for an invasive strategy		*Randomized trial of 25,086 patients with an acute coronary syndrome referred for an invasive strategy
	**Double dose clopidogrel (a 600-mg loading dose on day 1, followed by 150 mg daily for 6 days		**Double dose clopidogrel (a 600-mg loading dose on day 1, followed by 150 mg daily for 6 days
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	*No difference between high dose and low dose clopidogrel or asprin.		*No difference between high dose and low dose clopidogrel or asprin.

	~~CHAMP: p MI no benefit c coumadin plus ASA 81 vs 162.~~

	~~HTN~~



	===FRISC<ref>Low-molecular-weight heparin during instability in coronary artery disease, Fragmin during Instability in Coronary Artery Disease (FRISC) study group.Lancet. 1996 Mar 2;347(9001):561-8</ref>===		===FRISC<ref>Low-molecular-weight heparin during instability in coronary artery disease, Fragmin during Instability in Coronary Artery Disease (FRISC) study group.Lancet. 1996 Mar 2;347(9001):561-8</ref>===
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	*4-5 months after the end of treatment, there were no significant differences in the rates of death, new myocardial infarction, or revascularisation		*4-5 months after the end of treatment, there were no significant differences in the rates of death, new myocardial infarction, or revascularisation

	===GUSTO IV- ACS~~===~~		===GUSTO Trial<ref>The GUSTO IV-ACS Investigators. Effect of glycoprotein IIb/IIIa receptor blocker abciximab on outcome in patients with acute coronary syndromes without early coronary revascularisation: the GUSTO IV-ACS randomised trial. Lancet 2001; 357: 1915-1924[http://download.thelancet.com/pdfs/journals/lancet/PIIS0140673600050601.pdf?id=caarQytUnFmG9h6iqGvuu PDF]</ref>===
			*Multi-center Randomized Placebo Controlled Trial
			*7800 patients
	Lancet 2001;357:1915		**randomly assigned placebo or
			**abciximab bolus and 24 h infusion or
	-~~>No benefit from abciximab in USA~~/~~NSTEMI s early invasive tx~~.		**abciximab bolus and 48 h infusion
			**all patients received aspirin and either unfractionated or low-molecular-weight heparin
	7800 ~~pt c USA/NSTEMI & TnI~~ or ~~ST depression. ASA & UFH/LMWH c placebo,~~ abciximab 24 h, or abciximab ~~48h. 30 d death~~ or ~~MI 8.O% vs 8.2 vs 9.1 (nonsignificant). 48h also s~~ benefit.		*No benefit in the abciximab groups



	===LIFE===		===LIFE===

Ostermayer at 00:17, 31 March 2014

2014-03-31T00:17:25Z

← Older revision		Revision as of 00:17, 31 March 2014
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	===Aspirin in MI<ref>Lewis HD et al. Protective effects of aspirin against acute myocardial infarction and death in men with unstable angina. Results of a Veterans Administration Cooperative Study. N Engl J Med. 1983 Aug 18;309(7):396-403</ref>===		===Aspirin in MI<ref>Lewis HD et al. Protective effects of aspirin against acute myocardial infarction and death in men with unstable angina. Results of a Veterans Administration Cooperative Study. N Engl J Med. 1983 Aug 18;309(7):396-403</ref>===
			*VA Patients
			*Primary end points were death and acute myocardial infarction diagnosed by the presence of creatine kinase MB or pathologic Q-wave changes on electrocardiograms.
			*Multicenter, double-blind, placebo-controlled randomized trial of aspirin treatment (324 mg in buffered solution daily) for 12 weeks in 1266 men with unstable angina

	*VA Cooperative		*At 12 weeks ASA group had 51% decrease in death & MI. 1

	*At ~~12w asa~~ had 51% ~~dec~~ in death & MI. 1~~,266 men c USA 324mq ASA vs placebo.~~

	===Aspirin or Sulfinpyrazone<ref>Cairns J et al. Aspirin, Sulfinpyrazone, or Both in Unstable Angina — Results of a Canadian Multicenter Trial. N Engl J Med. 1985 Nov 28;313(22):1369-75</ref>===		===Aspirin or Sulfinpyrazone<ref>Cairns J et al. Aspirin, Sulfinpyrazone, or Both in Unstable Angina — Results of a Canadian Multicenter Trial. N Engl J Med. 1985 Nov 28;313(22):1369-75</ref>===
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	===ATACS<ref>Cohen M et al. Combination antithrombotic therapy in unstable rest angina and non-Q-wave infarction in nonprior aspirin users. Primary end points analysis from the ATACS trial. Antithrombotic Therapy in Acute Coronary Syndromes Research Group. Circulation. 1994 Jan;89(1):81-8 [http://circ.ahajournals.org/content/89/1/81.full.pdf PDF]</ref>===		===ATACS<ref>Cohen M et al. Combination antithrombotic therapy in unstable rest angina and non-Q-wave infarction in nonprior aspirin users. Primary end points analysis from the ATACS trial. Antithrombotic Therapy in Acute Coronary Syndromes Research Group. Circulation. 1994 Jan;89(1):81-8 [http://circ.ahajournals.org/content/89/1/81.full.pdf PDF]</ref>===
	* Coumadin & ASA shows no long term benefit~~(e.q. ATACS)~~		Two hundred fourteen patients were randomized to receive aspirin alone (162.5 mg daily) or a combination of aspirin plus anticoagulation
			**Aspirin 162.5 mg daily plus heparin (activated partial thromboplastin time, two times control) followed by aspirin 162.5 mg daily plus warfarin (international normalized ratio, 2 to 3)
			* Coumadin & ASA shows no long term benefit


	OASIS ~~pilot moderat dose dec by 58%~~.		===OASIS-5 TRIAL<ref>Efficacy and safety of fondaparinux versus enoxaparin in patients with acute coronary syndromes treated with glycoprotein IIb/IIIa inhibitors or thienopyridines: results from the OASIS 5 (Fifth Organization to Assess Strategies in Ischemic Syndromes) trial.J Am Coll Cardiol. 2009 Jul 28;54(5):468-76 [http://www.sciencedirect.com/science/article/pii/S0735109709016015/pdfft?md5=83ac965b2708e83c211a770660723d91&pid=1-s2.0-S0735109709016015-main.pdf PDF]</ref>===
			*Double-blinded multicenter RCT in 20,078 patients with UA/NSTEMI
			*Given Fondaparinux 2.5mg daily vs Enoxaparin 1mg/kg in patients receiving GP IIb/IIIa inhibitors
			*Primary endpoint was to determine whether fondaparinux was superior to enoxaparin in preventing major bleeding.
			*n patients receiving GP IIb/IIIa inhibitors or thienopyridines, fondaparinux reduces major bleeding

	~~OASIS-2: 3712 pts ASA plus moderate coumadin. CVD/MI/CVA p 5 months was 7.65% vs 8.4%.~~

	~~CARS was discountinued early c NO benefit c~~ either 1 or 3 mg ~~plus 81mg ASA vs 160 ASA~~. ~~Lancet 997; 350:389~~.		OASIS-7<ref>The CURRENT–OASIS 7 Investigator. Dose Comparisons of Clopidogrel and Aspirin in Acute Coronary Syndromes [http://www.nejm.org/doi/pdf/10.1056/NEJMoa0909475 PDF]</ref>
			*Randomized trial of 25,086 patients with an acute coronary syndrome referred for an invasive strategy
			**Double dose clopidogrel (a 600-mg loading dose on day 1, followed by 150 mg daily for 6 days
			and 75 mg daily thereafter)
			**Standard-dose clopidogrel (a 300-mg loading dose and 75 mg daily thereafter)
			***Plus either higher-dose aspirin (300 to 325 mg daily) or lower-dose aspirin (75 to 100 mg daily).
			*No difference between high dose and low dose clopidogrel or asprin.

	CHAMP: p MI no benefit c coumadin plus ASA 81 vs 162.		CHAMP: p MI no benefit c coumadin plus ASA 81 vs 162.

Ostermayer: /* FRISC */

2014-03-30T23:36:37Z

FRISC

← Older revision		Revision as of 23:36, 30 March 2014
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	===FRISC~~===~~		===FRISC<ref>Low-molecular-weight heparin during instability in coronary artery disease, Fragmin during Instability in Coronary Artery Disease (FRISC) study group.Lancet. 1996 Mar 2;347(9001):561-8</ref>===
			*1,506 patients with Unstable Anginat or NSTEMI given Dalteparin bid x 6d then QD x 35-45d.
			*63% reduction in death or MI in first 6days.
	Lancet 1996; 347:561		*4-5 months after the end of treatment, there were no significant differences in the rates of death, new myocardial infarction, or revascularisation

	1,506 ~~pt c USA~~ or ~~NQWMI c~~ Dalteparin bid x 6d then QD x 35-45d. 63% reduction in death or MI in first ~~6d. Still seen at 40 days but excess events when dose decreased~~.



	===GUSTO IV- ACS===		===GUSTO IV- ACS===

Ostermayer: /* TIMI 11B */

2014-03-30T03:24:27Z

TIMI 11B

← Older revision		Revision as of 03:24, 30 March 2014
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			<references/>
	[[Category:Cards]]		[[Category:Cards]]

Ostermayer at 03:24, 30 March 2014

2014-03-30T03:24:10Z

← Older revision		Revision as of 03:24, 30 March 2014
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	*Prolonged nadroparin treatment was associated with an increase in major bleeding events and equal short term efficacy		*Prolonged nadroparin treatment was associated with an increase in major bleeding events and equal short term efficacy

	===ATACS<ref>Cohen M et al. Combination antithrombotic therapy in unstable rest angina and non-Q-wave infarction in nonprior aspirin users. Primary end points analysis from the ATACS trial. Antithrombotic Therapy in Acute Coronary Syndromes Research Group. Circulation. 1994 Jan;89(1):81-8 [http://circ.ahajournals.org/content/89/1/81.full.pdf PDF]===		===ATACS<ref>Cohen M et al. Combination antithrombotic therapy in unstable rest angina and non-Q-wave infarction in nonprior aspirin users. Primary end points analysis from the ATACS trial. Antithrombotic Therapy in Acute Coronary Syndromes Research Group. Circulation. 1994 Jan;89(1):81-8 [http://circ.ahajournals.org/content/89/1/81.full.pdf PDF]</ref>===
	* Coumadin & ASA shows no long term benefit(e.q. ATACS)		* Coumadin & ASA shows no long term benefit(e.q. ATACS)