Table 3.
Large scale clinical outcome trials investigating genetic tests guided personalized antiplatelet therapy
| NCT number | Title | Status | Indication (number) |
Design | Test | Methods | Primary end point |
|---|---|---|---|---|---|---|---|
| NCT00995514 | Genotype Guided Comparison of Clopidogrel and Prasugrel Outcomes Study (GeCCO) | Terminated | ACS (14,600) | Observational Cohort | CYP2C19*2 | Prasugrel 10mg in LOF alleles vs. Clopidogrel 75mg control. | Composite of CV death, nonfatal MI, or non-fatal stroke at 6 months |
| NCT01452152 | Pharmacogenomics of Anti-platelet Intervention-2(PAPI-2) | Terminated | PCI (7,200) | Randomized | CYP2C19*2 or *3 | Genotype directed group: prasugrel 5–10 mg/day for IM and PM, Clopidogrel for other genotype. vs. Observational group: no Intervention and standard of care without genetic information | Composite of non-fatal MI, non-fatal stroke, ST and death secondary to any cardiovascular cause at 12 months |
| NCT01177592 | Thrombocyte Activity Reassessment and GEnoTyping for PCI (TARGET-PCI) | Terminated | PCI (1,500) | Randomized | CYP2C19*2 | CYP2C19*2 carriers: Prasugrel 60mg,vs. Others: clopidogrel 75mg | Composite of cardiovascular death, ischemic stroke, non-fatal myocardial infarction, urgent target vessel revascularization at 6 months |
| NCT01761786 | Cost-effectiveness of Genotype Guided Treatment With Antiplatelet Drugs in STEMI Patients: Optimization of Treatment (POPGenetics,) | Recruiting | Primary PCI (2,700) | Randomized | CYP2C19*2 or *3 | Wild type CYP2C19 allele: clopidogrel 75 mg. vs. CYP2C19*2 and *3: ticagrelor or prasugrel. | Composite of non-fatal MI, non-fatal stroke, CV death, and ST Pharmacoeconomics |
| NCT01134380 | Genotyping Infarct Patients to Adjust and Normalize Thienopyridine Treatment (GIANT) | Completed | Primary PCI (1,500) | Observational Case Control | CYP2C19*2 | Physician can change or adjust initial DAPT regimen after notification of result of genetic test (Increase of the clopidogrel dosage, Change drug to prasugrel or clopidogrel) | Composite of death, MI and ST at 12 months |
| NCT01742117 | Tailored Antiplatelet Therapy Following PCI (TAILOR-PCI) | Recruiting | PCI (5,270) | Randomized | CYP2C19*2 or *3 | Wild type CYP2C19 allele: clopidogrel 75 mg. vs. CYP2C19*2 and *3: ticagrelor 90 mg. | Composite of non-fatal MI, non-fatal stroke, CV death, severe recurrent ischemia, and ST at 12 months |
| NCT02508116 | Assessment of Prospective CYP2C19 Genotype Guided Dosing of Anti-Platelet Therapy in Percutaneous Coronary Intervention (ADAPT) | Recruiting | PCI (700) | Randomized | CYP2C19*2 or *3 | The genotype guided arm: prasugrel or ticagrelor in LOF carrier and clopidogrel in non-carrier. vs. Control group: usual antiplatelet treatment. | Cost of medical service utilization. MACEs at 12 months |
LOF, loss-of-function; CV, cardiovascular; MI, myocardial infarction; IM, intermediate metabolizer; PM, poor metabolizer; DAPT, dual antiplatelet treatment; ST, stent thrombosis; MACEs, major adverse cardiovascular events