Table. Cardiovascular Genotype-based Clinical Trials.
Trial | TAILOR PCI |
POPular Genetics Study |
COAG | EU-PACT | Genetic AF |
---|---|---|---|---|---|
Study Population | Post-PCI ACS, Stable CAD, STEMI |
Post-PCI, STEMI | Any indication for warfarin initiation |
AF or venous thromboembolism |
Persistent AF, recent cardioversion to sinus |
Sample Size | 5,270 | 2,700 | 1,022 | 455 | 620 |
Pharmacogenetic Marker |
CYP2C19*2 or *3 | CYP2C19*2 or *3 |
CYP2C9 and VKORC1 |
CYP2C9*2 or *3 and VKORC1 (−1639G→A) |
ADRB1 (389 Arg/Arg) |
Treatment Arms | Genotyping arm (clopidogrel in WT + ticagrelor in CYP2C19*2 or *3 carriers) vs Non- genotyping arm (clopidogrel) |
Genotyping arm (clopidogrel in WT + ticagrelor or prasugrel in CYP2C19*2 or *3 carriers) vs non- genotyping arm (ticagrelor) |
Genotyping arm (Warfarin dose based on genotype + clinical variables) vs non-genotyping arm (Warfarin dose based on clinical variables) |
Genotyping arm (Warfarin dose based on genotype and clinical variables) vs non- genotyping arm (fixed Warfarin dosing) |
Bucindolol vs Metoprolol in B1 389 Arg/Arg carriers |
Trial Design | Pragmatic, open label, randomized prospective, modified- enrichment superiority study |
Open label, randomized, prospective, non- inferiority marker- based strategy study |
Double-blind, randomized, prospective, marker-based- strategy superiority trial |
Pragmatic, single- blind, randomized, marker-based strategy superiority trial |
Double-blind, 2–arm, active-controlled, adaptive–designed, enriched superiority study |
Primary Endpoints | Composite of CV death, stroke, MI, ST, urgent revascularization |
Composite of death, stroke, MI, ST, urgent revascularization, major bleeding. |
Percentage of time in therapeutic INR |
Percentage of time in therapeutic INR |
Time to first event of symptomatic AF/atrial flutter or all-cause mortality. |
Results | Currently recruiting | Currently recruiting | Genotyping guided dosing not superior to conventional warfarin dosing |
Genotyping guided dosing superior to conventional fixed warfarin dosing |
Currently recruiting |
References | Clinicaltrials.gov: NCT01742117 |
Clinicaltrials.gov: NCT01761786 |
12 | 13 | Clinicaltrials.gov: NCT01970501 |