The magnitude of platelet inhibition and the pharmacokinetics of a 600 mg loading dose of clopidogrel, in different patient categories (stable angina versus acute-coronary syndromes versus ST-elevated myocardial infarction).

The magnitude of platelet inhibition and the pharmacokinetics of a 600 mg loading dose of clopidogrel, in different patient categories (stable angina versus acute-coronary syndromes versus ST-elevated myocardial infarction). - The MAPCAT-study

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON33697

Enrollment

200

Registered

2007-02-15

Start date

2006-12-01

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with a history of a stent thrombosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Group 1: Patients with a history of a stent thrombosis in the period 2002-2009. Group 2: Patients with ACS or stable AP.

Exclusion criteria

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 ( aemoglobin 600 x 109/L) Known allergy to clopidogrel Pregnancy (present or suspected) Uncontrolled hypertension at time of randomization

Design outcomes

Primary

Measure	Time frame
1) To investigate whether platelet function is significantly different between patients with a history of stent thrombosis and controls (stable anginga and ACS) . 2) To investigate whether plasma pharmacokinetics (represented by Cmax, Tmax and the AUC) of unchanged clopidogrel and its active thiol metabolite and its inactive carboxyl metabolite are significantly different between patients with a history of stent thrombosis and controls (stable angina and ACS) .	—

Measure

Time frame

1) To investigate whether platelet function is significantly different between patients with a history of stent thrombosis and controls (stable anginga and ACS) . 2) To investigate whether plasma pharmacokinetics (represented by Cmax, Tmax and the AUC) of unchanged clopidogrel and its active thiol metabolite and its inactive carboxyl metabolite are significantly different between patients with a history of stent thrombosis and controls (stable angina and ACS) .

—

Secondary

Measure	Time frame
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.	—

Countries

Netherlands

Outcome results