Different Anti-Spastic Therapy Strategies After CABG Using Radial Artery Grafts

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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 screened according to the inclusion and exclusion criteria. Estimated 150 patients will be enrolled and randomized by ratio 1:1:1 to receive either Nicorandil (5mg tid po) or Diltiazem (180mg qd po) or Isosorbide Mononitrate (50mg qd po). Follow-up visits will be conducted at Day 7, 28, 84, 168 after surgery. The last evaluation of study endpoints and other adverse events will be at Day 168.

The pilot study is designed to explore the angiography outcomes of grafts and cardiovascular outcomes of patients, as well as safety outcomes among different anti-spastic regimens after RA-CABG.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ruijin Hospital
• Collaborator: Chugai Pharma China
• Treatments: Diltiazem; Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate; Nicorandil

Criteria

Inclusion Criteria:

• Age≥18 years old，

• Male or female patients，

• Have signed informed consent，

• Have successfully received a RA-CABG surgery 1-3 days ago.

Exclusion Criteria:

• 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 .