Tailoring Of Platelet Inhibition to Avoid Stent Thrombosis

NCT ID: NCT00914368

Last Updated: 2010-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-03-31

Brief Summary

The primary objective of this study is to establish a cut off level of platelet inhibition that separates patients with or without previous stent occlusion with acute clinical onset while on aspirin and clopidogrel treatment within 6 months after coronary stenting for coronary artery disease.

Detailed Description

To establish cut off levels of platelet inhibition using ADP-induced P2Y12-receptor mediated platelet aggregation using Accumetrics VerifyNow P2Y12 assay (PRU) and Vasodilator-stimulated phosphoprotein (VASP, PRI %)for patients with experienced stent occlusion with acute clinical onset and/or myocardial infarction within 6 months after coronary stenting for coronary artery disease.

Conditions

Coronary Artery Disease; Myocardial Infarction; Stent Thrombosis; Heart Diseases; Acute Coronary Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

1

Patients with previously experienced stent thrombosis while on dual antiplatelet treatment within 6 months after coronary stenting for coronary artery disease

Group Type: ACTIVE_COMPARATOR

Clopidogrel

Intervention Type: DRUG

Patients not already on clopidogrel treatment a loading dose of clopidogrel 600 mg followed by a maintenance dose of 75 mg once daily will be administered.

2

Patients with previously experienced myocardial infarction while on dual antiplatelet treatment within 6 months after coronary stenting for coronary artery disease

Group Type: ACTIVE_COMPARATOR

Clopidogrel

Intervention Type: DRUG

Patients not already on clopidogrel treatment a loading dose of clopidogrel 600 mg followed by a maintenance dose of 75 mg once daily will be administered.

3

Patients without previously experienced myocardial infarction or stent thrombosis 6 within months after coronary stenting for coronary artery disease(matched controls for group 1 and 2)

Group Type: ACTIVE_COMPARATOR

Clopidogrel

Intervention Type: DRUG

Patients not already on clopidogrel treatment a loading dose of clopidogrel 600 mg followed by a maintenance dose of 75 mg once daily will be administered.

Interventions

Clopidogrel

Patients not already on clopidogrel treatment a loading dose of clopidogrel 600 mg followed by a maintenance dose of 75 mg once daily will be administered.

Intervention Type: DRUG

Other Intervention Names

Plavix

Eligibility Criteria

Inclusion Criteria

• Provide signed written informed consent.
• Male or female patients above 18 years old.
• Previous PCI and coronary stenting for coronary artery disease
• Previous (after coronary stenting) or current dual antiplatelet treatment (aspirin 75 mg once daily (o.d) and clopidogrel 75 mg o.d). All patients need to be on treatment with aspirin 75 mg once daily at least seven days prior to enrollment.
• Experienced one of the following alternatives:

• Stent thrombosis within 6 months of PCI while on dual antiplatelet treatment; OR
• Experienced MI within 6 month after coronary stenting while on dual antiplatelet treatment; OR
• No experience of stent thrombosis or MI for at least 6 months and until visit 1 (matched control)

Exclusion Criteria

1. Women who are known to be pregnant, who have given birth within the past 90 days, or who are breastfeeding.

2. Any condition or laboratory findings which in the opinion of the Investigator makes the patient unsuitable for inclusion

3. Enrolled in either another investigational drug study or in another investigational study of an approved drug within 30 days prior to Visit 1 of the current study.

4. Known allergies or intolerance to aspirin and/or thienopyridines (clopidogrel or ticlopidine).

5. Significant active neuropsychiatric disease, alcohol abuse or drug abuse, in the investigator's opinion.

6. UCR or Accumetrics employees or investigator site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.

7. Subjects with unstable coronary artery disease, defined as new, increased, or rest angina at screening.

8. Subjects with significant hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure >110 mmHg) at the time of screening.

9. Any known contraindication to treatment with an anticoagulant or antiplatelet agent.

10. Prior history or presence of significant bleeding disorders (for example,hematemesis, melena, severe or recurrent epistaxis, hemoptysis, hematuria, or intraocular bleeding)

11. Prior history or clinical suspicion of cerebral vascular malformations

12. Prior history of abnormal bleeding tendency (i.e. prolonged bleeding on dental extraction, tonsillectomy, or previous surgical procedure).

13. Personal or family history of coagulation or bleeding disorders.

14. Thrombocytopenia (platelet count < 100,000/mm3) or thrombocytosis (platelet count > 500,000/mm3).

15. History of major surgery, severe trauma, organ biopsy within 3 months prior to enrollment.

16. Any planned surgical procedure within 20 days following inclusion.

17. The use (or planned use) of other antiplatelet agents (besides aspirin and clopidogrel), anticoagulant or fibrinolytic agents.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

UCR, Uppsala University

Principal Investigators

Lars Wallentin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University, Uppsala Clinical Research Center

Locations

Uppsala Clinical Research Center

Uppsala, , Sweden

Countries

Sweden

Other Identifiers

U-08-002

Identifier Type: -

Identifier Source: org_study_id