Coronary Artery Bypass GraftPhase 4ASRAB-PilotNCT04310995
Different Anti-Spastic Therapy Strategies After CABG Using Radial Artery Grafts
A Phase 4 study testing Nicorandil 5mg tid, Diltiazem 180mg qd and Isosorbide Mononitrate 50mg qd in people with Coronary Artery Bypass Graft and Radial Artery Grafts, run by Ruijin Hospital at 1 site in China.
Trial summary
The Pilot study will be a single-center, randomized, open-label, active-controlled trial. After CABG surgery using Radial Artery Grafts (RA-CABG) and signing the informed consent, all patients will be screened according to the inclusion and exclusion criteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass Graft, Radial Artery Grafts, Antispastic Therapy
- What is being tested?
- Nicorandil 5mg tid, Diltiazem 180mg qd and Isosorbide Mononitrate 50mg qd
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 2 Jun 2020to 31 May 2026
- 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，
- Male or female patients，
- Have signed informed consent，
- Have successfully received a RA-CABG surgery 1-3 days ago.
Who cannot join
- Previously experienced an allergy to active ingredients and/or excipients of experimental drugs,
- Hypotension (defined as systolic blood pressure < 90mmHg or diastolic blood pressure < 60mmHg) after surgery,
- Acute myocardial infarction, pulmonary congestion or cardiogenic shock after surgery,
- Concomitant medications with phosphodiesterase-5 inhibitors such as sildenafil, vardenafil, tadalafil, etc,
- Pathological sinus node syndrome, degree II or III atrioventricular block without cardiac pacemaker,
- With contraindications for coronary computed tomography angiography (CCTA) or coronary arteriography (CAG) examination, such as iodine allergy, etc. note: patients with renal insufficiency or even end-stage receiving hemodialysis but can be tolerated by CCTA or CAG examination (judged by investigators) are eligible for inclusion,
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- History or evidence of ongoing alcohol or drug abuse,
- Life expectancy < 1 year judged by investigators,
- Other inappropriate situations judged by investigators .
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, 200025
About this study
Official title: Effect of Nicorandil, Diltiazem or Isosorbide Mononitrate for Oral Antispastic Therapy After Coronary Artery Bypass Grafting Using Radial Artery Grafts - A Pilot Randomized Controlled Trial
The Pilot study will be a single-center, randomized, open-label, active-controlled trial. After CABG surgery using Radial Artery Grafts (RA-CABG) and signing the informed consent, all patients will be screened according to the inclusion and exclusion criteria. Estimated 150 patients will be enrolled and randomized by ratio 1:1:1 to receive either Nicorandil (5mg tid po) or Diltiazem (180mg qd po) or Isosorbide Mononitrate (50mg qd po). Follow-up visits will be conducted at Week 1, 4, 12, and 24 after surgery. The last evaluation of study endpoints and other adverse events will be at Week 24.
The pilot study is designed to explore the angiography outcomes of grafts and cardiovascular outcomes of patients, as well as safety outcomes among different anti-spastic regimens after RA-CABG.
The original study plan included a 24-week follow-up to evaluate the effects of different antispasmodic medications on radial artery grafts. The study protocol has been updated to include a centralized follow-up at a median of 5 years post-surgery. During this follow-up, patients' survival status, imaging results of graft vessels, and major cardiovascular events will be collected via outpatient visits or telephone interviews, with the aim of evaluating the impact of different antispasmodic strategies on long-term clinical outcomes and graft patency.
Read the detailed description
After having signed informed consent (Day 1-3), eligible subjects who have successfully received first RA-CABG surgery (Day 0) will be screened for enrollment. All subjects (150 patients) will be randomized in a 1:1:1 ratio into 3 groups. Group A will receive oral Nicorandil (5mg tid) monotherapy; Group B will receive oral Diltiazem (180mg qd) monotherapy; and Group C will receive Isosorbide Mononitrate (50mg qd) monotherapy. Three groups will continue intervention treatment for 24 weeks after RA-CABG surgery. All subjects will receive follow-up visits (clinic visit or phone visit) at Week 1, 4, 12, and 24 after surgery.
All subjects will receive first CCTA (or CAG) to evaluate the graft outcome at Week 1 and second CCTA (or CAG) to evaluate the graft outcome at Week 24 after RA-CABG surgery. And all subjects will be evaluated angina relief based on the Canadian Cardiovascular Society (CCS) angina grading and the Seattle Angina Questionnaire. And the time to first major adverse cardiovascular event (MACE), which include all-cause mortality, myocardial infarction, stroke and unplanned revascularization, will be collected. And other safety outcomes will be evaluated, including the rate of hypotension, the proportion of concomitant medications with ACEI/ARB/ARNI drugs and proportion of SAEs and concerned AEs.
This 5-year extended follow-up study plans to conduct centralized follow-up visits (outpatient or telephone) with study participants. Data to be collected during the follow-up include: survival status (if deceased, date and cause of death), all CCTA or CAG results obtained from the time of surgery up to this follow-up visit, all clinical events meeting the definition of study endpoints and their date of occurrence, medical records related to clinical events (e.g., outpatient records, discharge summaries, laboratory results, imaging reports), and current concomitant medication information. For deceased patients, death and cause of death will first be determined by telephone interview with relatives. If available, relevant medical records will be obtained from their relatives to further ascertain the cause of death.
- Being tested
- Nicorandil 5mg tid, Diltiazem 180mg qd, Isosorbide Mononitrate 50mg qd
- Keywords
- CABG, Radial artery grafts, Antispastic, Nicorandil, Diltiazem, Isosorbide Mononitrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicorandil 5mg tidDrug
oral Nicorandil Tablets 5mg (5mg per tablet) three times daily for 24 weeks
Diltiazem 180mg qdDrug
oral Diltiazem Sustained-release Tables180mg (90 mg per tablet) once daily for 24 weeks
Isosorbide Mononitrate 50mg qdDrug
oral Isosorbide Mononitrate Sustained-release Capsules 50 mg (50mg per capsule) once daily for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Nicorandil | Experimental | Not described Receives: Drug: Nicorandil 5mg tid |
| Diltiazem | Experimental | Not described Receives: Drug: Diltiazem 180mg qd |
| Isosorbide Mononitrate | Experimental | Not described Receives: Drug: Isosorbide Mononitrate 50mg qd |
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 1
CCTA or CAG will be used to evaluate the RA graft outcome at Week 1 after RA-CABG. The definition of RA-graft outcomes will refer to the modified Fitzgibbon classification criteria. When RA-graft outcome conform to the Grade B, O or S, the result will be judged as the graft failure.
Measured: at Week 1
the rate of RA graft failure at Week 24
CCTA or CAG will be used to evaluate the RA graft outcome at at Week 24 after RA-CABG. The definition of RA-graft outcomes will refer to the modified Fitzgibbon classification criteria. When RA-graft outcome conform to the Grade B, O or S, the result will be judged as the graft failure.
Measured: at Week 24
Secondary outcomes (7)
the time to first Major Adverse Cardiovascular Events (MACE)
MACE will include all-cause death, myocardial infarction, stroke and unplanned revascularization.
Measured: within 24 weeks
the proportion of subjects with angina recurrence
The angina symptoms will be evaluated by Canadian Cardiovascular Society angina grade and Seattle Angina Questionnaires.
Measured: within 24 weeks
the proportion of subjects with at least one hypotension occurrence
Subjects' blood pressure will be measured by sitting in the clinic or by using a sphygmomanometer outside the hospital (recorded on the diary card). Systolic blood pressure < 90mmHg or diastolic blood pressure < 60mmHg will be recorded as "hypotension" as defined in the study.
Measured: within 24 weeks
the proportion of subjects with ACEI/ARB/ARNI withdrawal
The subjects who stop using ACEI/ARB/ARNI ≥20% of the time during the study period will be recorded as "ACEI/ARB/ARNI withdrawal" as defined in the study.
Measured: within 24 weeks
the proportion of subjects with serious adverse events (SAEs) and concerned adverse events (AEs)
SAE will include death; life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability/incapacity; a congenital anomaly/birth defect in the offspring of the patient; judged to be medically significant (including laboratory abnormalities). concerned AEs will include: cardiac arrest, reoperation, incision complications, pulmonary infection, respiratory failure, new atrial fibrillation/atrial flutter, permanent pacemaker implantation, and gastrointestinal hemorrhage.
Measured: within 24 weeks
Time to First Radial Artery Graft Failure during Extended Follow-up
Assessed by coronary computed tomography angiography (CCTA) or coronary angiography (CAG). Graft failure is defined as Fitzgibbon grade O or S according to the modified Fitzgibbon classification.
Measured: within the extended follow-up period (median follow-up of 5 years).
Time to First Composite Event during Extended Follow-up
Composite of cardiovascular death, myocardial infarction, stroke, unplanned revascularization of RA graft target vessel, and RA graft failure (modified Fitzgibbon grade O or S) during the extended follow-up period.
Measured: within the extended follow-up period (median follow-up of 5 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start2 Jun 2020
- Primary completion2 Feb 2023
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery Bypass GraftStudies 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
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chugai Pharma China
- Responsible party
- Principal investigator, Qiang Zhao,MD, Ruijin Hospital
- Investigators
- Qiang Zhao, MD.PhD, Principal investigator, Ruijin HospitalYunpeng Zhu, MD, Study director, Ruijin HospitalMario FL Gaudino, MD, Principal investigator, Weill Cornell Medicine NewYork Presbyterian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310995
- Sponsor's protocol ID
- SIG-IIS001C
- Acronym
- ASRAB-Pilot
- Status last verified
- Jul 2026
- First submitted
- 10 Mar 2020
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhu Y, Zhang W, Qin K, Liu Y, Yao H, Wang Z, Ye X, Zhou M, Li H, Qiu J, Xu H, Sun Y, Gaudino M, Zhao Q. Effects of Nicorandil, Isosorbide Mononitrate, or Diltiazem on Radial Artery Grafts After CABG: The Randomized ASRAB-Pilot Trial. Circ Cardiovasc Interv. 2025 Apr;18(4):e014542. doi: 10.1161/CIRCINTERVENTIONS.124.014542. Epub 2025 Mar 24.
PubMed 40123490