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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001105

Enrollment

Registered

2008-04-01

Start date

2006-08-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vasospastic Angina Pectoris

Interventions

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: administ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with coronary vasospasm, and categorized at least one of following 2 conditions 1)patients who is positive of ischemic ST-segment change when chest pain appears at rest, or patients who is negative with exercise test. 2)Patients with coronary vasospasm and show ischemic ST-segment change on electrocardiogram by selective acetylcholine or ergonovine -loading test

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactYuji Oikawa

The Cardiovascular Institute Department of Cardiovascular Medicine

oikawa@cvi.or.jp03-3408-2151

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026