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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2030-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Isosorbide Mononitrate + 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

Group Type EXPERIMENTAL

Oral isosorbide mononitrate 4+ amlodipine

Intervention Type 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

Blank control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No