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

NCT06730945 | Withdrawn Phase 4

• 1 other identifier: KY-2025-XXX
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

CABG; Radial artery grafts; Isosorbide Mononitrate; Amlodipine

Outcome Measures

Primary Outcomes (1)

• The rate of RA graft failure at Week 24

  A protocol-driven CCTA will be used to evaluate the RA graft outcome at Week 24 after CABG. Fitzgibbon Grade B/S/O is definned as Graft Failure.

  at Week 24

Secondary Outcomes (2)

• The time to first Major Adverse Cardiovascular Event (MACE)

  within 24 weeks

• The proportion of participants with at least once symptomatic hypotension

  within 24 weeks

Study Arms (2)

Isosorbide Mononitrate + Amlodipine

EXPERIMENTAL

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

Drug: Oral isosorbide mononitrate 4+ amlodipine

Blank control

NO INTERVENTION

no use of any nitrates or CCBs for 24 weeks after CABG. if there are indications of hypertension, use RAASi rather than CCB.

Interventions

Oral isosorbide mononitrate 4+ amlodipine DRUG

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

Isosorbide Mononitrate + Amlodipine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥18 years old，
• Any sex，
• Signed informed consent，
• Within 3 days after primary isolated CABG using RA graft

You may not qualify if:

• Allergy to isosorbide mononitrate or amlodipine.
• Hypotension (systolic BP \<90 mmHg or diastolic BP \<60 mmHg)
• Acute myocardial infarction or cardiogenic shock
• Contraindications for CCTA examination (eg., iodine allergy)

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

Study Officials

• Qiang Zhao, MD

  Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China

  PRINCIPAL INVESTIGATOR

• Mario FL Gaudino, MD

  Weill Cornell Medicine NewYork Presbyterian Hospital, NY, US

  PRINCIPAL INVESTIGATOR

• Yunpeng Zhu, MD

  Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director of Cardiovascular Surgery

Study Record Dates

• First Submitted: December 7, 2024
• First Posted: December 12, 2024
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2030
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

CN (1)