Platelet Function Monitoring in Patients Treated With Clopidogrel at the Time of Primary Percutaneous Coronary Angioplasty

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Platelets are a major component of clot formation which can lead to clotting events such as heart attack. During treatment for a heart attack, doctors try to remove this blockage as quickly as possible so that the heart can recover and start to work properly again. The standard of care at the Heart Institute for patients having a heart attack is a procedure called a Percutaneous Coronary Angioplasty. A drug called Clopidogrel (Plavix) is routinely used prior to the angioplasty to prevent blood clots. Patients usually remain on Clopidogrel for at least one year following the angioplasty. Clopidogrel works by preventing the blood from forming sticky substances called platelets, which clump together to form clots. Despite the routine use of Clopidogrel, some patients still return to the hospital with another heart attack, or with more chest pain. There is a growing body of evidence that recurrence of these complications may be attributed to some patients having a poor response to Clopidogrel.

This pilot study will examine how platelets react to different doses of Clopidogrel given to patients having a heart attack.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ottawa Heart Institute Research Corporation
• Treatments: Clopidogrel; Ticlopidine

Criteria

Inclusion Criteria:

1. Ischemic chest discomfort of greater than 30 minutes duration

2. Onset of chest pain less than 12 hrs prior to entry into the study

3. ST segment elevation of > 1 mm (0.1 mV) in two or more contiguous electrocardiographic leads (on a standard 12 lead ECG) or left bundle branch block not known to be old

Exclusion Criteria:

1. Active bleeding

2. GI or GU bleed within 2 weeks, or any major bleeding episode within 2 weeks

3. Stroke within 90 days or intracranial bleeding at any time

4. Major surgery or trauma within the past six weeks

5. Uncontrolled hypertension (SBP > 200 mm Hg and/or DBP > 110 mm Hg despite treatment)

6. Prolonged (>10 min) cardiopulmonary resuscitation

7. Inadequate vascular access

8. PCI within the last 30 days

9. Thrombolytic agents within the preceding 7 days

10. GP IIb/IIIa antagonists within the preceding 7 days

11. Coagulation disorder (i.e. INR >2.0, platelets <100,000 / mm3, or hematocrit <30%)

12. Current warfarin treatment

13. A subcutaneous therapeutic dose of any LMWH within 12 hours

14. Intolerance to aspirin or clopidogrel

15. Patient already on chronic clopidogrel therapy

16. Other medical condition that is likely to result in death within 12 months

17. Participation in a study with another investigational device or drug < four weeks

18. Pregnancy

19. Known severe renal impairment (creatinine clearance rate of less than 30 ml per minute)

20. Sustained hypotension defined as SBP < 80 mmHg or the need for IV inotropes and/or intraaortic balloon counterpulsation to support the blood pressure

21. Known severe contrast (dye) allergy

22. Inability to provide informed consent