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

Shanghai Jiao Tong University

Status and phase: Begins enrollment this month; Phase 4

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

Treatments: Drug: Oral isosorbide mononitrate 4+ amlodipine

Study type: Interventional

Funder types: Other

Identifiers

NCT06730945

KY-2025-XXX

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 2 patient groups

Isosorbide Mononitrate + Amlodipine

Experimental group

Description:

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

Treatment:

Drug: Oral isosorbide mononitrate 4+ amlodipine

Blank control

No Intervention group

Description:

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