Table 2. On-going randomized controlled trials.
| Trial | Clinical Trials.gov ID | N | A Fib | Test arm | Control arm | Duration | Endpoint |
|---|---|---|---|---|---|---|---|
| POPular TAVI | 2247128 | 1,000 | Yes, Cohort B | Cohort A: clopidogrel 75 mg for 3 months | Cohort A: clopidogrel 75 mg for 3 months + aspirin 100 mg for 1 year | 12 months | Primary: freedom from non-procedure-related bleeding at 1 year |
| Cohort B: OAC | Cohort B: OAC + clopidogrel 75 mg for 3 months | Secondary: freedom from cardiovascular death, non-procedure-related bleeding, MI, or stroke at 1 year | |||||
| GALILEO | 2556203 | 1,520 | No | Rivaroxaban 10 mg long term + aspirin 75 mg for 3 months | Aspirin 75 mg long term + clopidogrel 75 mg for 3 months | Up to 25 months | Primary efficacy: composite of all-cause death, stroke, systemic embolism, MI, pulmonary embolism, deep venous thrombosis, and symptomatic valve thrombosis |
| Primary safety: composite of life-threatening, disabling and major bleeding | |||||||
| ATLANTIS | 2664649 | 1,510 | Yes | Stratum 1 and 2: apixaban 5 mg twice daily (renal dose reduction) | Stratum 1: VKA | Up to 13 months | Composite of death, MI, systemic emboli, intracardiac or bioprosthetic thrombus, deep venous thrombosis, pulmonary embolism or major bleeding at 1 year |
| Stratum 2: SAPT/ DAPT | |||||||
| AVATAR | 2735902 | 170 | Yes | OAC only | OAC + antiplatelet agent (aspirin/clopidogrel) | 12 months | Composite of all-cause death, MI, stroke, valve thrombosis, and bleeding |
| AUREA | 0162134 | 124 | No | Aspirin 80 mg + clopidogrel 75 mg/day | VKA | 3 months | Thromboembolic cerebrovascular events on MRI |
| ENVISAGE | 02943785 | 1,400 | Yes | Edoxaban | VKA | 36 months | Primary efficacy: all-cause death, MI, ischemic stroke, systemic embolization, valve thrombosis |
| Primary safety: major bleeding | |||||||
| CLOE* | pending | ? | Yes, Cohort B | Cohort A: aspirin 75 mg for 6 months | Cohort A: Aspirin 75 mg + clopidogrel 75 mg for 6 months | 6 months | Primary efficacy: composite endpoint of death, MI, stroke, and valve thrombosis |
| Cohort B: VKA | Cohort B: VKA + clopidogrel 75 mg daily for 6 months | Primary safety: life-threatening and major bleeding | |||||
| WATCH-TAVR | 03173534 | 312 | Yes | Watchman LAAO device | Optimal medical therapy | 12 months | Composite of all-cause mortality, stroke and bleeding |
*, CLOE trial has been announced but further details are pending. N, number of patients expected to be enrolled; A Fib, atrial fibrillation; OAC, oral anticoagulation; SAPT, single antiplatelet therapy; DAPT, dual antiplatelet therapy; VKA, vitamin K antagonist; MI, myocardial infarction; MRI, magnetic resonance imaging.