Active — Not RecruitingPhase 4

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

China150 participantsStarted 2020-06-02

Plain-language 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. 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 .

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

the rate of RA graft failure at Week 1

Timeframe: at Week 1

the rate of RA graft failure at Week 24

Timeframe: at Week 24

Trial details

NCT IDNCT04310995

SponsorRuijin Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-02

View on ClinicalTrials.gov More Coronary Artery Bypass Graft trials