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Effect of Oral Isosorbide Mononitrate Plus Amlodipine Antispasm Therapy on Outcomes of Radial Artery Grafts After CABG

NCT06730945 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2025-09-17

No results posted yet for this study

Summary

The goal of this clinical trial is to to evaluate the effect of oral isosorbide mononitrate plus amlodipine antispasm therapy on outcomes of radial artery grafts in patients underwent primary isolated CABG.

The main question it aims to answer is:

Whether the oral isosorbide mononitrate plus amlodipine antispasm therapy could reduce the failure outcome of radial artery grafts after CABG .

Researchers will compare isosorbide mononitrate plus amlodipine to none to see if isosorbide mononitrate plus amlodipine works.

Participants will

1. Take oral isosorbide mononitrate (20-40mg daily) plus amlodipine (2.5-5mg daily) therapy for 24 weeks after CABG.
2. Clinical follow-up at Week 1, 4, 12, and 24 after CABG.
3. Protocol-driven CCTA at Week 24 after CABG.

Conditions

  • Coronary Artery Bypass Graft Surgery (CABG)
  • Radial Artery Grafts
  • Graft Failure

Interventions

DRUG

Oral isosorbide mononitrate 4+ amlodipine

Oral isosorbide mononitrate 40mg (if unable to tolerate, 20mg) once daily + amlodipine 5mg (if unable to tolerate, 2.5mg) once daily for 24 weeks after CABG

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Principal Investigators

  • Qiang Zhao, MD · Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China

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

  • Yunpeng Zhu, MD · Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2028-12-31
Completion
2030-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06730945 on ClinicalTrials.gov