NCT04347330

Cardiovascular Risk Reduction in Atrial Fibrillation Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,675 (estimated)
• Sponsor: Beijing Anzhen Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Atrial fibrillation (AF) is a serious public health problem because of its increasing incidence and prevalence in the aging population. AF is associated with elevated risks of death, stroke, coronary event, heart failure, cognitive decline, and chronic kidney disease. To identify preventive interventions for major cardiovascular events beyond effective anticoagulation should be a major priority in the treatment of AF patients. The CRAFT study is a 2-arm, multicenter, randomized clinical trial designed to test whether intensive blood pressure control will reduce the risk of major cardiovascular events in AF patients.

Detailed description

The CRAFT trial will include approximately 1675 AF patients with home SBP 125-154 mmHg and at least another cardiovascular risk factor. The trial aims to compare the effects of randomization to a treatment program of an intensive SBP goal (target home SBP \<120mmHg) with randomization to a treatment program of a standard goal (target home SBP \<135mmHg). The primary hypothesis is that cardiovascular event rates will be lower in the intensive arm. Participants will be recruited over a 4-year period at approximately 100 to 150 clinical centres and the first patient will be followed for up to 5 years.

Conditions

• Atrial Fibrillation
• Hypertension

Interventions

Type	Name	Description
DRUG	Intensive BP Control	Participants in the Intensive group have a goal of home SBP \<120 mm Hg. The CRAFT BP treatment protocol is flexible in terms of the choice and doses of antihypertensive medications, but there should be preferences among the drug classes, based on CVD outcome trials results and current guidelines. Use of once-daily antihypertensive agents will be encouraged unless alternative frequency is indicated/necessary. Combination of different classes of agents are encouraged to achieve the home SBP goal. Medications will not be provided by the CRAFT study.
DRUG	Standard BP Control	Participants in the Standard group has a goal of home SBP \<135 mmHg. The same principle of BP treatment in the Intensive BP arm will be used for the Standard BP arm. Medications will not be provided by the CRAFT study.

Timeline

• Start date: 2020-08-31
• Primary completion: 2024-06-01
• Completion: 2025-12-01
• First posted: 2020-04-15
• Last updated: 2023-12-11

Locations

1 site across 1 country: China