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.
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
- Are there results?
- None posted in the registry
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
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 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:
Read more
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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiang Zhao,MD, Ruijin Hospital
- Investigators
- Qiang Zhao, MD, Principal investigator, Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaMario FL Gaudino, MD, Principal investigator, Weill Cornell Medicine NewYork Presbyterian Hospital, NY, USYunpeng Zhu, MD, Study director, Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06730945
- Acronym / sponsor ID
- ASRAB / KY-2025-XXX
- Keywords
- CABG, Radial artery grafts, Isosorbide Mononitrate, Amlodipine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Modify the trial design and construct a new larger trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 12 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isosorbide Mononitrate + Amlodipine | Experimental | Drug: Oral isosorbide mononitrate 4+ amlodipineOral 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 |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age≥18 years old，
- Any sex，
- Signed informed consent，
- Within 3 days after primary isolated CABG using RA graft
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral isosorbide mononitrate 4+ amlodipineOral 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 | Drug | Isosorbide Mononitrate + Amlodipine |
Primary outcome
The rate of RA graft failure at Week 24
Time frame: 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.
2 secondary outcomes
The time to first Major Adverse Cardiovascular Event (MACE)
Time frame: within 24 weeks
The proportion of participants with at least once symptomatic hypotension
Time frame: within 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qiang Zhao, MD principal investigator
Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China
Mario FL Gaudino, MD principal investigator
Weill Cornell Medicine NewYork Presbyterian Hospital, NY, US
Yunpeng Zhu, MD study director
Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of RA graft failure at Week 24 (time frame: at Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.