Cardiovascular Risk Reduction in Atrial Fibrillation Trial

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.

Conditions

• Atrial Fibrillation
• Hypertension

Interventions

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.

Sponsors & Collaborators

• Heart Health Research Center

  collaborator OTHER

• The George Institute for Global Health, China

  collaborator OTHER

• The George Institute for Global Health, Australia

  collaborator OTHER

• Fukuoka University

  collaborator OTHER

• Beijing Anzhen Hospital

  lead OTHER

Principal Investigators

• Changsheng Ma, Doctor · Beijing Anzhen Hospital

• Craig S Anderson, Doctor · The George Institute for Global Health, China; Heart Health Research Centre

• Jianzeng Dong, Doctor · Beijing Anzhen Hospital; The First Affiliated Hospital of Zhengzhou University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-31

Primary Completion

2024-06-30

Completion

2025-12-31

Countries

• China

Study Locations