Status:
COMPLETED
Different Anti-Spastic Therapy Strategies After CABG Using Radial Artery Grafts
Lead Sponsor:
Ruijin Hospital
Collaborating Sponsors:
Chugai Pharma China
Conditions:
Coronary Artery Bypass Graft
Radial Artery Grafts
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The Pilot study will be a single-center, randomized, open-label, active-controlled trial. After CABG surgery using Radial Artery Grafts (RA-CABG) and signing the informed consent, all patients will be...
Detailed Description
After having signed informed consent (Day 1-3), eligible subjects who have successfully received first RA-CABG surgery (Day 0) will be screened for enrollment. All subjects (150 patients) will be rand...
Eligibility Criteria
Inclusion
- Age≥18 years old，
- Male or female patients，
- Have signed informed consent，
- Have successfully received a RA-CABG surgery 1-3 days ago.
Exclusion
- Previously experienced an allergy to active ingredients and/or excipients of experimental drugs,
- Hypotension (defined as systolic blood pressure \< 90mmHg or diastolic blood pressure \< 60mmHg) after surgery,
- Acute myocardial infarction, pulmonary congestion or cardiogenic shock after surgery,
- Concomitant medications with phosphodiesterase-5 inhibitors such as sildenafil, vardenafil, tadalafil, etc,
- Pathological sinus node syndrome, degree II or III atrioventricular block without cardiac pacemaker,
- With contraindications for coronary computed tomography angiography (CCTA) or coronary arteriography (CAG) examination, such as iodine allergy, etc. note: patients with renal insufficiency or even end-stage receiving hemodialysis but can be tolerated by CCTA or CAG examination (judged by investigators) are eligible for inclusion,
- History or evidence of ongoing alcohol or drug abuse,
- Life expectancy \< 1 year judged by investigators,
- Other inappropriate situations judged by investigators .
Key Trial Info
Start Date :
June 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04310995
Start Date
June 2 2020
End Date
June 28 2023
Last Update
December 12 2024
Active Locations (1)
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1
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, China, 200025