FindTrial
Sign In

Double-blind, placebo-controlled, randomized clinical trial of Fasudil for refractory coronary vasospasm during cardiac catheterization/treatment.

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2091220366
Enrollment
26
Registered
2018-07-23
Start date
2018-08-01
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

refractory coronary vasospasm

Interventions

Intervention type:DRUG Name of intervention:fasudil hydrochloride hydrate Dose form / Japanese Medical Device Nomenclature:INJECTION Route of administration / Site of application:INTRACORONARY Dose pe

Sponsors

Hiroaki Shimokawa
Lead Sponsor
Tohoku University, Nihon University, Fujita Health University, Yamaguchi University, Kurume University, Kumamoto University, JR Hiroshima Hospital, Sakakibara Heart Institute, Yokohama City University Medical Center, National Cerebral and Cardiovascular Center
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
The proportion of cases in which it was adjudicated that refractory coronary vasospasm was ameliorated based on the images of coronary angiography.—

Secondary

MeasureTime frame
1) Improvement of ischemic ECG change 2) Improvement of symptoms of myocardial ischemia 3) Changes in stenosis on coronary angiography—

Countries

Japan

Contacts

Public ContactTakashi Shiroto, Kotaro Nochioka

Tohoku University Hospital

c44chiken@crieto.hosp.tohoku.ac.jp+81-22-717-7135

Outcome results

None listed

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