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

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

• Chugai Pharma China

  collaborator UNKNOWN

• Ruijin Hospital

  lead OTHER

Principal Investigators

• Qiang Zhao, MD.PhD · Ruijin Hospital

• Yunpeng Zhu, MD · Ruijin Hospital

• Mario FL Gaudino, MD · Weill Cornell Medicine NewYork Presbyterian Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-02

Primary Completion

2023-02-02

Completion

2026-05-31

Countries

• China

Study Locations