genotype-guided strategy for antithrombotic treatment versus conventional clopidogrel therapy in peripheral arterial disease’

INTERVENTION: Trade Name: Clopidogrel Product Name: Clopidogrel Pharmaceutical Form: Coated tablet Trade Name: Clopidogrel Product Name: Clopidogrel Pharmaceutical Form: Coated tablet Trade Name: Rivaroxaban Product Name: Rivaroxaban Pharmaceutical Form: Coated tablet Trade Name: Aspirin Product Name: Aspirin Pharmaceutical Form: Coated tablet CONDITION: Symptomatic or stable pheripheral artery disease Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: Main Objective: The primary aim of the GENPAD study is to evaluate the ability of genotype‐guided antithrombotic treatment to reduce adverse clinical events related to arterial thrombosis in PAD patients. Adverse clinical events related to arterial thrombosis include death from any cause, major adverse cardiovascular events (myocardial infarction, stroke, transient ischemic attack) and major adverse limb events (acute/chronic limb ischemia, peripheral vascular intervention including amputation). Primary end point(s): The primary outcome is the occurrence of adverse clinical events at 24 months, including death from any cause, major adverse cardiovascular events and major adverse limb events. Secondary Objective: To assess the risk of clinically relevant bleedings in patients allocated to the genotype‐guided antiplatelet treatment versus standard clopidogrel prescription.; ; To evaluate the ability of genotype‐guided antithrombotic treatment to reduce the separate elements of the primary composite outcome. Timepoint(s) of evaluation of this end point: 24 months SECONDARY OUTCOME: Secondary end point(s): Secondary endpoints are the occurrence of the separate elements of the primary composite outcome at 24 months. ; ; The secondary safety outcome will be major and clinically relevant minor bleeding complications. Timepoint(s) of evaluation of this end point: 24 months INCLUSION CRITERIA: ‐ age > 16 years ‐ obtained written informed consent ‐ indication for monotherapy clopidogrel 75mg once daily ‐ ankle‐brachial index < 0.9 and/or toe brachial index < 0.5 ‐ current or previous symptoms due to insufficient vascularization of one or two lower extremities, including intermittent claudication, pain at rest and/or gangrene (Rutherford category 1‐6) ‐ consulting a vascular surgeon for diagnosis, treatment and/or follow‐up of PAD symptoms Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 744 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1500