Double-blind, placebo-controlled, randomized clinical trial of Fasudil for refractory coronary vasospasm during cardiac catheterization/treatment.
- Conditions
- refractory coronary vasospasm
- Registration Number
- JPRN-jRCT2091220366
- Lead Sponsor
- Hiroaki Shimokawa
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
1. Patients who are planned to undergo cardiac catheterization including percutaneous coronary intervention.
2. Male patients or female patients without the possibility of pregnancy.
3. Patients who are able and willing to provide written informed consent.
4. Patients who are confirmed to have been occurring refractory coronary vasospasm during cardiac catheterization/treatment.
1. Patients with cardiogenic shock or those with congestive heart failure who need continuous intravenous infusion of inotropic drugs or vasodilators at the enrollment.
2. Patients who undergo urgent cardiac catheterization because of suspecting acute coronary syndrome etc.
3. Patients who have developed or suspected intracranial hemorrhage.
4. Patients who have previously received fasudil.
5. Patients who previously developed allergy to nitrates
6. Patients with severe hepatic disorder (either AST or ALT is >3 times the upper limit of normal).
7. Patients participating in other clinical trials or clinical research, excluding observational research without intervention.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of cases in which it was adjudicated that refractory coronary vasospasm was ameliorated based on the images of coronary angiography.
- Secondary Outcome Measures
Name Time Method 1) Improvement of ischemic ECG change<br>2) Improvement of symptoms of myocardial ischemia<br>3) Changes in stenosis on coronary angiography