NCT00914368

Tailoring Of Platelet Inhibition to Avoid Stent Thrombosis

TOPAS-1, A Pharmacodynamic Phase II Study of Clopidogrel P2Y12 Platelet Inhibition

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Uppsala University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2009-06-05
• Last updated: 2010-04-13

Locations

1 site across 1 country: Sweden