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

NCT00827346 | Completed Phase 2

• 2 other identifiers: MRL-A22008239-01H
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Platelet Reactivity

Outcome Measures

Primary Outcomes (1)

• The primary objective of this randomized pilot study is to evaluate the inhibition of platelet aggregation (IPA) amongst 4 different loading doses of clopidogrel in patients with STEMI treated with bivalirudin as anticoagulant for PCI

  Up to 48hrs

Secondary Outcomes (2)

• Clinical events (death reinfarction, stroke, bleeding)

  Up to 6 months

• The percent TIMI grade 3 coronary flow at first contrast injection on the base-line angiogram, to TIMI flow after the PCI,

  Pre and post ballon injection

Study Arms (4)

Group 1

ACTIVE COMPARATOR

600-mg double dose

Drug: Clopidogrel

Group 2

ACTIVE COMPARATOR

600/600-mg double loading dose (first dose 600 mg given immediately upon arrival at the hospital and the second dose 600 mg, 3 hours after the first loading dose for a total of 900 mg

Drug: Clopidogrel

Group 3

ACTIVE COMPARATOR

Clopidogrel 900mg

Drug: Clopidogrel

Group 4

ACTIVE COMPARATOR

First dose 600 mg given immediately upon arrival at the hospital and the second dose 300 mg, 3 hours after the first loading dose for a total of 900 mg

Drug: Clopidogrel

Interventions

Clopidogrel DRUG

600 mg now

Group 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Ischemic chest discomfort of greater than 30 minutes duration
• Onset of chest pain less than 12 hrs prior to entry into the study
• 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

You may not qualify if:

• Active bleeding
• GI or GU bleed within 2 weeks, or any major bleeding episode within 2 weeks
• Stroke within 90 days or intracranial bleeding at any time
• Major surgery or trauma within the past six weeks
• Uncontrolled hypertension (SBP \> 200 mm Hg and/or DBP \> 110 mm Hg despite treatment)
• Prolonged (\>10 min) cardiopulmonary resuscitation
• Inadequate vascular access
• PCI within the last 30 days
• Thrombolytic agents within the preceding 7 days
• GP IIb/IIIa antagonists within the preceding 7 days
• Coagulation disorder (i.e. INR \>2.0, platelets \<100,000 / mm3, or hematocrit \<30%)
• Current warfarin treatment
• A subcutaneous therapeutic dose of any LMWH within 12 hours
• Intolerance to aspirin or clopidogrel
• Patient already on chronic clopidogrel therapy

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

MeSH Terms

Interventions

Clopidogrel

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Michel R Le May, MD FRCPC FACC

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 20, 2009
• First Posted: January 22, 2009
• Study Start: January 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: April 29, 2011

Record last verified: 2011-04

Locations

CA (1)