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Different Anti-Spastic Therapy Strategies After CABG Using Radial Artery Grafts

NCT ID: NCT04310995

Last Updated: 2024-12-12

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-02

Study Completion Date

2023-06-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coronary Artery Bypass Graft Radial Artery Grafts Antispastic Therapy Pilot Study

Keywords

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CABG Radial artery grafts Antispastic Nicorandil Diltiazem Isosorbide Mononitrate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nicorandil

Group Type EXPERIMENTAL

Nicorandil 5mg tid

Intervention Type DRUG

oral Nicorandil Tablets 5mg (5mg per tablet) three times daily for 24 weeks

Diltiazem

Group Type EXPERIMENTAL

Diltiazem 180mg qd

Intervention Type DRUG

oral Diltiazem Sustained-release Tables180mg (90 mg per tablet) once daily for 24 weeks

Isosorbide Mononitrate

Group Type EXPERIMENTAL

Isosorbide Mononitrate 50mg qd

Intervention Type DRUG

oral Isosorbide Mononitrate Sustained-release Capsules 50 mg (50mg per capsule) once daily for 24 weeks

Interventions

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Nicorandil 5mg tid

oral Nicorandil Tablets 5mg (5mg per tablet) three times daily for 24 weeks

Intervention Type DRUG

Diltiazem 180mg qd

oral Diltiazem Sustained-release Tables180mg (90 mg per tablet) once daily for 24 weeks

Intervention Type DRUG

Isosorbide Mononitrate 50mg qd

oral Isosorbide Mononitrate Sustained-release Capsules 50 mg (50mg per capsule) once daily for 24 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age≥18 years old，
* Male or female patients，
* Have signed informed consent，
* Have successfully received a RA-CABG surgery 1-3 days ago.

Exclusion Criteria

* 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,
* History or evidence of ongoing alcohol or drug abuse,
* Life expectancy \< 1 year judged by investigators,
* Other inappropriate situations judged by investigators .
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chugai Pharma China

UNKNOWN

Sponsor Role collaborator

Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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Qiang Zhao,MD

Vice President of RuijinHospital, Professor and Director, Department of Cardiac Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Qiang Zhao, MD.PhD

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Yunpeng Zhu, MD

Role: STUDY_DIRECTOR

Ruijin Hospital

Mario FL Gaudino, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Cornell Medicine NewYork Presbyterian Hospital

Locations

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Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, , China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 40123490 (View on PubMed)

Other Identifiers

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SIG-IIS001C

Identifier Type: -

Identifier Source: org_study_id