Coronary Artery Bypass Graft Surgery (CABG)Phase 4ASRABNCT06730945

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

A Phase 4 study testing Oral isosorbide mononitrate 4+ amlodipine in people with Coronary Artery Bypass Graft Surgery (CABG) and Radial Artery Grafts, run by Ruijin Hospital at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Bypass Graft Surgery (CABG), Radial Artery Grafts, Graft Failure
What is being tested?: Oral isosorbide mononitrate 4+ amlodipine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteChina
Study dates: Jun 2025to Dec 2030
Phase: Phase 4

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

China1 site

Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai

Other trials in China

About this study

Official title: 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 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

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

Conditions: Coronary Artery Bypass Graft Surgery (CABG), Radial Artery Grafts, Graft Failure
Being tested: Oral isosorbide mononitrate 4+ amlodipine
Keywords: CABG, Radial artery grafts, Isosorbide Mononitrate, Amlodipine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oral isosorbide mononitrate 4+ amlodipineDrug
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

Study groups in NCT06730945
Study group	Role	What they receive
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 Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: at Week 24

Secondary outcomes (2)

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.
Measured: within 24 weeks
The proportion of participants with at least once symptomatic hypotension
Measured: within 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2025Dec 2030

First posted12 Dec 2024
Study startJun 2025 (estimated)
Primary completionDec 2028 (estimated)
Study completionDec 2030 (estimated)

Why it stopped: Modify the trial design and construct a new larger trial.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Coronary Artery Bypass Graft Surgery (CABG)Studies of the same condition, open and under way.
More trials run by Ruijin HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06730945
Sponsor's protocol ID: KY-2025-XXX
Acronym: ASRAB
Status last verified: Sep 2025
First submitted: 7 Dec 2024
Last updated: 17 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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