Cardiovascular Risk Reduction in Atrial Fibrillation Trial
Overview
- Phase
- Not Applicable
- Intervention
- Intensive BP Control
- Conditions
- Atrial Fibrillation
- Sponsor
- Beijing Anzhen Hospital
- Enrollment
- 1675
- Locations
- 1
- Primary Endpoint
- Hierarchical composite cardiovascular outcomes
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Chang sheng Ma
Director of Cardiology
Beijing Anzhen Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Intensive BP Control
Participants randomized into the Intensive BP Control arm will have a goal of home SBP \<120mmHg. For most participants in the Intensive Group, a two- or three-drug regimen should be initiated at randomization. Following the randomization visit, addition of another drug or medication dose titration is indicated if home SBP is ≥120 mmHg. Monthly visits will continue in the Intensive Group until home SBP \<120 mmHg or no more titration planned. If the home SBP is not \<120 mmHg at the every 6-month visit, then an antihypertensive drug from a class different from what is being taken should be added, rather than up-titration the dosage of previous drugs, unless there are compelling reasons against this practice.
Intervention: Intensive BP Control
Standard BP Control
Participants randomized into the Standard BP Control arm will have a goal of home SBP \<135mmHg. The Standard BP protocol is designed to achieve a home SBP of 130-134 mmHg in as many participants as possible. Following the randomization visit, medication dose titration or addition of another drug is indicated if home SBP ≥135 mmHg. Monthly visits will continue in the Standard Group when home SBP ≥155 mmHg. Down titration (a reduction of the dose or number of antihypertensive drugs) should be carried out if the home SBP is \<125 mmHg.
Intervention: Standard BP Control
Outcomes
Primary Outcomes
Hierarchical composite cardiovascular outcomes
Time Frame: 5 years
a hierarchical composite of cardiovascular death, number of strokes, time to first stroke, number of MI, time to first MI, number of HF, and time to first HF
Secondary Outcomes
- Main secondary cardiovascular outcomes(5 years)
- Main secondary renal outcomes(5 years)
- All-cause mortality(5 years)
- Change of the concern of falling(5 years)
- Change of the health state utility(5 years)
- Change of the self-report depression(5 years)
- Change of the self-report anxiety(5 years)
- Change of the frailty(5 years)