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

A Multicenter, Randomized, Outcomes Assessor Blind, Parallel Controlled Trial to Evaluate the Effect of Oral Isosorbide Mononitrate Plus Amlodipine Antispasm Therapy on Outcomes of Radial Artery Grafts After Coronary Artery Bypass Grafting

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.

Study Overview

• Status: Withdrawn
• Conditions: Graft Failure; Radial Artery Grafts; Coronary Artery Bypass Graft Surgery (CABG)
• Intervention / Treatment: Drug: Oral isosorbide mononitrate 4+ amlodipine

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Principal Investigator: 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; Study Director: Yunpeng Zhu, MD, Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: December 7, 2024
• First Submitted That Met QC Criteria: December 8, 2024
• First Posted (Actual): December 12, 2024

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: CABG; Amlodipine; Radial artery grafts; Isosorbide Mononitrate
• Additional Relevant MeSH Terms: Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Diuretics; Natriuretic Agents; Calcium Channel Blockers; Vasodilator Agents; Antihypertensive Agents; Diuretics, Osmotic; Nitric Oxide Donors; Amlodipine; Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate
• Other Study ID Numbers: KY-2025-XXX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No