Comparison of therapeutic effects of long-acting calcium channel blockers on coronary vasospasm.; Open label randomized trial (ATTACK VSA TRIAL)

UMIN ID: UMIN000001105

Registered date:01/04/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Vasospastic Angina Pectoris
• Date of first enrollment: 2006/08/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Benidipine administration group: administrate a Benidipine 4mg tablet twice a day after breakfast and supper. The dose can be changed according to the symptom
Nifedipine administration group: administrate a nifedipine 40 mg tablet after supper. The dose can be changed according to the symptom but maximum dose should be 60mg/once/day

Outcome(s)

• Primary Outcome: 1. comparison the numbers of episode(times/week) or the consumption of the short-acting nitrates (tablets/week) between before and after of treatment 2. Efficacy rate: Evaluate 2 treatment groups each by following five degree. 1) well improved, 2) improved, 3) less improved, 4) no change, 5) deterioration, 6) impossible to judge, after consideration following subjects, such as number and severity of episodes, consumption of short-acting nitrates, and total impression, together in each group. 3. Improvement of 24 hours electrocardiogram: (When the measurement was carried out in an institution) Evaluate 2 treatment groups each by following 3 degree. 1) improved, 2) no change, 3) deterioration, 4) impossible to judge, after consideration following subjects, such as number of ST rising, maximum degree of ST rising, or continuance time of ST rising, together in each group. 4. entire improvement: after consideration of #2 and #3, evaluate both treatment groups by following five degrees, and compare both groups 1) well improved, 2) improved, 3) less improved, 4) no change, 5) deterioration, 6) impossible to judge 5. About above end-points of #1 to #4, compare both treatment groups according to a patient background

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. patients who have organic coronary narrowing only but don't have coronary vasospasm 2. patient with acute myocardial infarction (within one month) 3. diabetes mellitus patients with poorly-controlled glycemia 4. severe hypertensive patients(>=180/>=110mmHg) 5. patients who is not able to administrate dihydropyridine calcium channel blockers 6. Patients who is not allowed to enroll the trial by doctor

Related Information

• Primary Sponsor: The Cardiovascular Institute
• Secondary Sponsor: Toranomon Hospital Toho University Ohashi Medical Center
• Source(s) of Monetary Support: None