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

NCT04310995 | Completed Phase 4

• 1 other identifier: SIG-IIS001C
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Coronary Artery Bypass Graft; Radial Artery Grafts; Antispastic Therapy; Pilot Study

Keywords

CABG; Radial artery grafts; Antispastic; Nicorandil; Diltiazem; Isosorbide Mononitrate

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  at Week 24

Secondary Outcomes (5)

• the time to first Major Adverse Cardiovascular Events (MACE)

  within 24 weeks

• the proportion of subjects with angina recurrence

  within 24 weeks

• the proportion of subjects with at least one hypotension occurrence

  within 24 weeks

• the proportion of subjects with ACEI/ARB/ARNI withdrawal

  within 24 weeks

• the proportion of subjects with serious adverse events (SAEs) and concerned adverse events (AEs)

  within 24 weeks

Study Arms (3)

Nicorandil

EXPERIMENTAL

Drug: Nicorandil 5mg tid

Diltiazem

EXPERIMENTAL

Drug: Diltiazem 180mg qd

Isosorbide Mononitrate

EXPERIMENTAL

Drug: Isosorbide Mononitrate 50mg qd

Interventions

Nicorandil 5mg tid DRUG

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

Nicorandil

Diltiazem 180mg qd DRUG

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

Diltiazem

Isosorbide Mononitrate 50mg qd DRUG

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

Isosorbide Mononitrate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ruijin Hospital: lead
• Chugai Pharma China: collaborator

Study Sites (1)

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, 200025, China

Location

Related Publications (1)

• 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.

  PMID: 40123490 DERIVED

MeSH Terms

Interventions

Nicorandil; Diltiazem; isosorbide-5-mononitrate

Intervention Hierarchy (Ancestors)

Nitrates; Organic Chemicals; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Qiang Zhao, MD.PhD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• Yunpeng Zhu, MD

  Ruijin Hospital

  STUDY DIRECTOR

• Mario FL Gaudino, MD

  Weill Cornell Medicine NewYork Presbyterian Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of RuijinHospital, Professor and Director, Department of Cardiac Surgery

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 17, 2020
• Study Start: June 2, 2020
• Primary Completion: February 2, 2023
• Study Completion: June 28, 2023
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

CN (1)