JPRN-jRCT2091220366CompletedPhase 3
Double-blind, placebo-controlled, randomized clinical trial of Fasudil for refractory coronary vasospasm during cardiac catheterization/treatment. - Rho-kinase inhibitor fasudil for refractory coronary vasospasm
Hiroaki Shimokawa0 sites26 target enrollmentStarted: July 23, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 26
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- ot applicable to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Investigators
Similar Trials
Active, not recruiting
Phase 1
Comparison of the efficacy and safety of Sialanar plus oral rehabilitation against placebo plus oral rehabilitation for children and adolescents with drooling and neurodisabiltiesSevere sialorrhoea and neurodisabilties in childrenEUCTR2020-005534-15-FRProveca Pharma LTD80
Active, not recruiting
Not Applicable
Double-blind, placebo-controlled, randomized clinical study of Broncho Vaxom in children suffering from recurrent upper respiratory tract infections - BV -2005/01 PRIMESRECURRENT UPPER RESPIRATORY TRACT INFECTIONSMedDRA version: 6.1Level: PTClassification code 10047482EUCTR2006-002980-17-ITOM PHARMA420
Completed
Not Applicable
Clinical trial to assess efficacy and safety of Cynanchum wilfordii Radix extract in subjects with elavated cholesterol levelsEndocrine, nutritional and metabolic diseaseKCT0003594TWOWINPHARMA120
Completed
Not Applicable
Improved immune defense by a proprietary larch arabinogalactaImmune functionInfections and InfestationsAcute upper respiratory infectionsISRCTN41183655onza Ltd (Switzerland)200
Active, not recruiting
Not Applicable
A clinical trial to demonstrate the safety and efficacy of a healingwater (Ensinger Schiller Quelle Heilwasser) on constipation compared to placebo- Functional constipation according to the ROME III criteria- The subjects have bowel movements 2 - 4 days/weekMedDRA version: 16.1Level: LLTClassification code 10029932Term: ObstipationSystem Organ Class: 100000004856EUCTR2013-000861-36-DEEnsinger Mineral-Heilquellen GmbH