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

Phase 4

Not yet recruiting

• Conditions: Coronary Artery Bypass Graft Surgery (CABG); Radial Artery Grafts; Graft Failure
• Interventions: Drug: Oral isosorbide mononitrate 4+ amlodipine

• Registration Number: NCT06730945
• Lead Sponsor: Ruijin Hospital

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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-07
• Study First Submitted QC: 2024-12-08
• Study First Posted: 2024-12-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29
• Study Start: 2025-06
• Primary Completion: 2028-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Isosorbide Mononitrate + Amlodipine	Oral isosorbide mononitrate 4+ amlodipine	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

Primary Outcome Measures

Name	Time	Method
The rate of RA graft failure at Week 24	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.

Secondary Outcome Measures

Name	Time	Method
The time to first Major Adverse Cardiovascular Event (MACE)	within 24 weeks	MACE is a composite of all-cause death, myocardial infarction（including peri-operative MI and silent MI), stroke and unplanned revascularization.
The proportion of participants with at least once symptomatic hypotension	within 24 weeks

Trial Locations

Locations (1)

Ruijin Hospital Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China