Warfarin After Anterior ST-Elevation Myocardial Infarction

NCT00662467 | Completed

• 1 other identifier: 06-281
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Following severe heart attacks involving the front wall of the heart (anterior myocardial infarction), patients are at risk of developing blood clots in the main pumping chamber that can cause a stroke. In the past, studies have shown that a blood thinner (warfarin) can decrease the risk of stroke and clot formation if administered to patients after an anterior myocardial infarction. However, in today's current practice, certain heart attack patients are commonly treated with two blood-thinning medications (aspirin and clopidogrel) to prevent recurrent heart attacks. Thus, a clinical problem is created as physicians are not clear how to treat patients after an anterior myocardial infarction who are at risk of a clot but require aspirin and clopidogrel to keep their blood vessels open. Adding warfarin to the combination of aspirin and clopidogrel will possibly decrease the risk of stroke but increase the risk of bleeding. Currently, there is no good evidence to help guide physicians. As demonstrated by a survey done at the Hamilton Health Sciences, there is a fifty/fifty split between physicians who use dual (aspirin and clopidogrel) versus triple (aspirin, clopidogrel, and warfarin) therapy in the treatment of similar patients as described above. The purpose of this study is to address the bleeding and stroke complications in patients after a severe anterior myocardial infarction. Half of the eligible patients will receive dual therapy and half will receive triple therapy. We will compare the incidence of stroke, blood clots, and bleeding complications between the two groups at 3 months.

Conditions

Myocardial Infarction

Keywords

Myocardial Infarction; Hemorrhage; Thromboembolism; Clopidogrel; Aspirin; Warfarin

Outcome Measures

Primary Outcomes (1)

• Combined death, MI, embolic event (TIA, stroke, non-cns emboli), Major Bleeding, and LVT (as determined by echocardiography) at 3 months

  3 months

Secondary Outcomes (1)

• Individual endpoints of LVT at discharge and at 3 months (determined by echocardiography), death, MI, stroke, TIA, non-CNS emboli, and minor bleeding

  3 months

Study Arms (2)

1

ACTIVE COMPARATOR

aspirin and clopidogrel

Drug: aspirin + clopidogrel

2

EXPERIMENTAL

aspirin, clopidogrel, and warfarin

Drug: aspirin + clopidogrel + warfarin

Interventions

aspirin + clopidogrel DRUG

Dual therapy

1

aspirin + clopidogrel + warfarin DRUG

Triple therapy

2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Anterior STEMI
• An ejection fraction less than 40% as per initial LV angiography or echocardiogram
• Randomization possible within hospital admission if anticoagulated with no interruption \> 24 hours
• Patient able and willing to give informed consent to participate in this trial

You may not qualify if:

• history of intracranial hemorrhage
• history of GI bleed last 6 months
• hemoglobin \< 90 g/L
• platelet count \< 100 x 10exp9/L
• ischemic stroke last 30 days
• intracranial tumor or aneurysm
• significant pericardial effusion
• severe renal failure (creatinine \> 250 mmol/L).

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

Hamilton Health Sciences-Hamilton General Hopsital

Hamilton, Ontario, L8L 2X2, Canada

Location

Related Publications (12)

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  PMID: 2794276 BACKGROUND

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  PMID: 7242633 BACKGROUND

• Meltzer RS, Visser CA, Fuster V. Intracardiac thrombi and systemic embolization. Ann Intern Med. 1986 May;104(5):689-98. doi: 10.7326/0003-4819-104-5-689.

  PMID: 3516044 BACKGROUND

• Kupper AJ, Verheugt FW, Peels CH, Galema TW, Roos JP. Left ventricular thrombus incidence and behavior studied by serial two-dimensional echocardiography in acute anterior myocardial infarction: left ventricular wall motion, systemic embolism and oral anticoagulation. J Am Coll Cardiol. 1989 Jun;13(7):1514-20. doi: 10.1016/0735-1097(89)90341-0.

  PMID: 2723267 BACKGROUND

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  PMID: 9555769 BACKGROUND

• Nayak D, Aronow WS, Sukhija R, McClung JA, Monsen CE, Belkin RN. Comparison of frequency of left ventricular thrombi in patients with anterior wall versus non-anterior wall acute myocardial infarction treated with antithrombotic and antiplatelet therapy with or without coronary revascularization. Am J Cardiol. 2004 Jun 15;93(12):1529-30. doi: 10.1016/j.amjcard.2004.02.066.

  PMID: 15194027 BACKGROUND

• Stratton JR, Lighty GW Jr, Pearlman AS, Ritchie JL. Detection of left ventricular thrombus by two-dimensional echocardiography: sensitivity, specificity, and causes of uncertainty. Circulation. 1982 Jul;66(1):156-66. doi: 10.1161/01.cir.66.1.156.

  PMID: 7083502 BACKGROUND

• Vaitkus PT, Barnathan ES. Embolic potential, prevention and management of mural thrombus complicating anterior myocardial infarction: a meta-analysis. J Am Coll Cardiol. 1993 Oct;22(4):1004-9. doi: 10.1016/0735-1097(93)90409-t.

  PMID: 8409034 BACKGROUND

• Weinreich DJ, Burke JF, Pauletto FJ. Left ventricular mural thrombi complicating acute myocardial infarction. Long-term follow-up with serial echocardiography. Ann Intern Med. 1984 Jun;100(6):789-94. doi: 10.7326/0003-4819-100-6-789.

  PMID: 6721297 BACKGROUND

• Chen ZM, Jiang LX, Chen YP, Xie JX, Pan HC, Peto R, Collins R, Liu LS; COMMIT (ClOpidogrel and Metoprolol in Myocardial Infarction Trial) collaborative group. Addition of clopidogrel to aspirin in 45,852 patients with acute myocardial infarction: randomised placebo-controlled trial. Lancet. 2005 Nov 5;366(9497):1607-21. doi: 10.1016/S0140-6736(05)67660-X.

  PMID: 16271642 BACKGROUND

• Sabatine MS, Blake GJ, Drazner MH, Morrow DA, Scirica BM, Murphy SA, McCabe CH, Weintraub WS, Gibson CM, Cannon CP. Influence of race on death and ischemic complications in patients with non-ST-elevation acute coronary syndromes despite modern, protocol-guided treatment. Circulation. 2005 Mar 15;111(10):1217-24. doi: 10.1161/01.CIR.0000157733.50479.B9.

  PMID: 15769761 BACKGROUND

• Antman EM, Anbe DT, Armstrong PW, Bates ER, Green LA, Hand M, Hochman JS, Krumholz HM, Kushner FG, Lamas GA, Mullany CJ, Ornato JP, Pearle DL, Sloan MA, Smith SC Jr, Alpert JS, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Gregoratos G, Halperin JL, Hiratzka LF, Hunt SA, Jacobs AK; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; Canadian Cardiovascular Society. ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1999 Guidelines for the Management of Patients with Acute Myocardial Infarction). Circulation. 2004 Aug 31;110(9):e82-292. No abstract available.

  PMID: 15339869 BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction; Hemorrhage; Thromboembolism

Interventions

Aspirin; Clopidogrel; Warfarin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Embolism and Thrombosis

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans

Study Officials

• Jon-David R Schwalm, MD, FRCPC

  McMaster University

  PRINCIPAL INVESTIGATOR

• Mayraj Ahmad, MD, FRCPC

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 8, 2008
• First Posted: April 21, 2008
• Study Start: November 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: April 21, 2008

Record last verified: 2008-04

Locations

CA (1)