Pharmacodynamic Outcomes in patients with coronary artery disease undergoing Percutaneous coronary intervention treated with an individualized treatment STRATEGY (POPular STRATEGY PD)

Conditions

Stable coronary artery disease, Chronic coronary syndrome

Brief summary

Platelet inhibition by measuring platelet reactivity units (PRU) using the VerifyNow at 30 days after randomization

Detailed description

Platelet reactivity measured using Light Transmission Aggregometry (LTA) and Total Thrombus formation Analysis System (T-TAS) at 30 days after randomization., The bleeding (safety) endpoint is the incidence of minor, moderate or severe bleeding (Bleeding Academic Research Consortium 2, 3 and 5) at 6 months., The efficacy endpoint is major adverse ischemic events (cardiovascular mortality, myocardial infarction, stent thrombosis, stroke, urgent target vessel revascularization) at 6 months, Individual components of the primary and secondary end points, Net clinical benefit (a composite of all-cause death, MI, stroke and major bleeding defined as BARC type 3 or 5 bleeding) at 6 months, The number of patients in whom the antiplatelet drug is prematurely discontinued or switched to another drug, The percentage of matching genotype results between the Genomadix and Genedrive test results in the intervention group.

Related papers

No related papers found yet.

Interventions

DRUGEfient 10 mg film-coated tablets.

DRUGPlavix 75 mg film-coated tablets

DRUGBrilique 90 mg film-coated tablets

DRUGAspirine 100

DRUG100 mg Tabletten

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Platelet inhibition by measuring platelet reactivity units (PRU) using the VerifyNow at 30 days after randomization	—

Secondary

Measure	Time frame
Platelet reactivity measured using Light Transmission Aggregometry (LTA) and Total Thrombus formation Analysis System (T-TAS) at 30 days after randomization., The bleeding (safety) endpoint is the incidence of minor, moderate or severe bleeding (Bleeding Academic Research Consortium 2, 3 and 5) at 6 months., The efficacy endpoint is major adverse ischemic events (cardiovascular mortality, myocardial infarction, stent thrombosis, stroke, urgent target vessel revascularization) at 6 months, Individual components of the primary and secondary end points, Net clinical benefit (a composite of all-cause death, MI, stroke and major bleeding defined as BARC type 3 or 5 bleeding) at 6 months, The number of patients in whom the antiplatelet drug is prematurely discontinued or switched to another drug, The percentage of matching genotype results between the Genomadix and Genedrive test results in the intervention group.	—

Measure

Time frame

Platelet reactivity measured using Light Transmission Aggregometry (LTA) and Total Thrombus formation Analysis System (T-TAS) at 30 days after randomization., The bleeding (safety) endpoint is the incidence of minor, moderate or severe bleeding (Bleeding Academic Research Consortium 2, 3 and 5) at 6 months., The efficacy endpoint is major adverse ischemic events (cardiovascular mortality, myocardial infarction, stent thrombosis, stroke, urgent target vessel revascularization) at 6 months, Individual components of the primary and secondary end points, Net clinical benefit (a composite of all-cause death, MI, stroke and major bleeding defined as BARC type 3 or 5 bleeding) at 6 months, The number of patients in whom the antiplatelet drug is prematurely discontinued or switched to another drug, The percentage of matching genotype results between the Genomadix and Genedrive test results in the intervention group.

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Countries

Netherlands

Outcome results

None listed