NCT04310995

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

Effect of Nicorandil, Diltiazem or Isosorbide Mononitrate for Oral Antispastic Therapy After Coronary Artery Bypass Grafting Using Radial Artery Grafts - A Pilot Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 Week 1, 4, 12, and 24 after surgery. The last evaluation of study endpoints and other adverse events will be at Week 24. 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. The original study plan included a 24-week follow-up to evaluate the effects of different antispasmodic medications on radial artery grafts. The study protocol has been updated to include a centralized follow-up at a median of 5 years post-surgery. During this follow-up, patients' survival status, imaging results of graft vessels, and major cardiovascular events will be collected via outpatient visits or telephone interviews, with the aim of evaluating the impact of different antispasmodic strategies on long-term clinical outcomes and graft patency.

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 randomized in a 1:1:1 ratio into 3 groups. Group A will receive oral Nicorandil (5mg tid) monotherapy; Group B will receive oral Diltiazem (180mg qd) monotherapy; and Group C will receive Isosorbide Mononitrate (50mg qd) monotherapy. Three groups will continue intervention treatment for 24 weeks after RA-CABG surgery. All subjects will receive follow-up visits (clinic visit or phone visit) at Week 1, 4, 12, and 24 after surgery. All subjects will receive first CCTA (or CAG) to evaluate the graft outcome at Week 1 and second CCTA (or CAG) to evaluate the graft outcome at Week 24 after RA-CABG surgery. And all subjects will be evaluated angina relief based on the Canadian Cardiovascular Society (CCS) angina grading and the Seattle Angina Questionnaire. And the time to first major adverse cardiovascular event (MACE), which include all-cause mortality, myocardial infarction, stroke and unplanned revascularization, will be collected. And other safety outcomes will be evaluated, including the rate of hypotension, the proportion of concomitant medications with ACEI/ARB/ARNI drugs and proportion of SAEs and concerned AEs. This 5-year extended follow-up study plans to conduct centralized follow-up visits (outpatient or telephone) with study participants. Data to be collected during the follow-up include: survival status (if deceased, date and cause of death), all CCTA or CAG results obtained from the time of surgery up to this follow-up visit, all clinical events meeting the definition of study endpoints and their date of occurrence, medical records related to clinical events (e.g., outpatient records, discharge summaries, laboratory results, imaging reports), and current concomitant medication information. For deceased patients, death and cause of death will first be determined by telephone interview with relatives. If available, relevant medical records will be obtained from their relatives to further ascertain the cause of death.

Conditions

• Coronary Artery Bypass Graft
• Radial Artery Grafts
• Antispastic Therapy
• Pilot Study

Interventions

Type	Name	Description
DRUG	Nicorandil 5mg tid	oral Nicorandil Tablets 5mg (5mg per tablet) three times daily for 24 weeks
DRUG	Diltiazem 180mg qd	oral Diltiazem Sustained-release Tables180mg (90 mg per tablet) once daily for 24 weeks
DRUG	Isosorbide Mononitrate 50mg qd	oral Isosorbide Mononitrate Sustained-release Capsules 50 mg (50mg per capsule) once daily for 24 weeks

Timeline

• Start date: 2020-06-02
• Primary completion: 2023-02-02
• Completion: 2026-05-01
• First posted: 2020-03-17
• Last updated: 2026-04-03

Locations

1 site across 1 country: China