Platelet Reactivity in Stent Thrombosis Patients (MAPCAT)

St. Antonius Hospital

Status and phase

Completed

Phase 4

Conditions

Coronary Artery Stent Thrombosis

Treatments

Drug: Clopidogrel

Study type

Interventional

Funder types

Other

Identifiers

NCT01012544

MAPCAT01

Details and patient eligibility

About

Recent studies have demonstrated a marked interindividual variability of clopidogrel's capacity to inhibit platelet aggregation with a substantial proportion (11-34%) of the patients considered non-responders to clopidogrel treatment. Variable intestinal absorption is suggested to contribute to the inconsistencies in response to clopidogrel. However, little is known about intestinal absorption in subjects who had suffered from a stent thrombosis. The MAPCAT-study has been designed to investigate whether plasma pharmacokinetics (represented by Cmax, Tmax and the AUC) after a 600 mg loading dose are significantly different between subjects who have suffered a stent thrombosis and subjects who have not suffered a stent thrombosis.

Full description

Objectives:

The first objective of the MAPCAT-study is to investigate whether plasma pharmacokinetics (Cmax, Tmax and AUC) of an additional 600 mg loading dose are impaired in patients with a history of stent thrombosis.

The second objective of the MAPCAT study is to investigate whether genetic polymorphisms in receptors, enzymes and ligands involved in the process of thrombosis and haemostasis as well in the conversion-process of clopidogrel into its metabolites do have influence on both the absolute magnitude of platelet inhibition and Cmax, Tmax and AUC.

Enrollment

187 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with a history of a stent thrombosis in the period 2004-2008.

Exclusion criteria

Persistent acute ST-segment elevation
Successful revascularization during the qualifying hospitalization, prior to study entry
Acute pulmonary edema, hypotension, or evidence of cardiogenic shock
Clinically significant liver disease
End stage kidney disease requiring dialysis
Use at study entry of drugs that are strong inhibitors of cytochrome P450 3A4 and CYP3A5 (i.e. clarithromycin, erythromycin, itraconazole, ketoconazole)
Contraindications to antithrombotic/antiplatelet therapy
Failed coronary intervention in the previous 2 weeks
Malignancies
Increased risk of bleeding (previous stroke in the past months, active bleeding or bleeding diathesis, recent trauma or major surgery in the last month, suspected aortic dissection, oral anticoagulation therapy with coumarin derivate within 7 days, recent use of GPIIb/IIIa inhibitors within 14 days, severe uncontrolled hypertension >180 mmHg unresponsive to therapy)
Relevant hematologic deviations (haemoglobin <100g/L (6,2 mmol/L) or hematocrit <34%, platelet count <100 x 109 /L or platelet count > 600 x 109/L)
Known allergy to clopidogrel
Pregnancy (present or suspected)
uncontrolled hypertension at time of randomization