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Different Anti-Spastic Therapy Strategies After CABG Using Radial Artery Grafts (ASRAB-Pilot)

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ClinicalTrials.gov Identifier: NCT04310995
Recruitment Status : Recruiting
First Posted : March 17, 2020
Last Update Posted : June 5, 2020
Sponsor:
Collaborator:
Chugai Pharma China
Information provided by (Responsible Party):
Qiang Zhao,MD, Ruijin Hospital

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 100 patients will be enrolled and randomized by ratio 1:1:1 to receive either Nicorandil (5mg tid po, n=34) or Diltiazem (180mg qd po, n=33) or Isosorbide Mononitrate (50mg qd po, n=33). Follow-up visits will be conducted at Day 7, 28, 84, 168 after surgery. The last evaluation of study endpoints and other adverse events will be at Day 168.

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.


Condition or disease Intervention/treatment Phase
Coronary Artery Bypass Graft Radial Artery Grafts Antispastic Therapy Pilot Study Drug: Nicorandil Drug: Diltiazem Hydrochloride Drug: Isosorbide Mononitrate 50 mg Phase 4

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 (about 100 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 168 days (24 weeks) after RA-CABG surgery. All subjects will receive follow-up visits (clinic visit or phone visit) at Day 7, 28, 84, and 168.

All subjects will receive first CCTA (or CAG) to evaluate the graft outcome at Day 7 and second CCTA (or CAG) to evaluate the graft outcome at Day 168 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Pilot Trial to Compare the Anti-Spastic Efficacy of Nicorandil, Diltiazem and Isosorbide Mononitrate Oral Therapy for Patients Undergoing Coronary Artery Bypass Grafting Using Radial Artery Grafts
Actual Study Start Date : June 2, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022


Arm Intervention/treatment
Experimental: Nicorandil
oral Nicorandil 5mg (Tablets) three times daily for 168 days
Drug: Nicorandil
oral Nicorandil Tablets 5mg (5mg per tablet) three times daily

Active Comparator: Diltiazem Hydrochloride
oral Diltiazem 180mg (Sustained-release Tablets) once daily for 168 days
Drug: Diltiazem Hydrochloride
oral Diltiazem Hydrochloride Sustained-release Tables180mg (90 mg per tablet) once daily

Active Comparator: Isosorbide Mononitrate
oral Isosorbide Mononitrate 50mg (Sustained-release Capsules) once daily for 168 days
Drug: Isosorbide Mononitrate 50 mg
oral Isosorbide Mononitrate Sustained-release Capsules 50 mg (50mg per capsule) once daily




Primary Outcome Measures :
  1. the rate of RA graft failure at Day 7 [ Time Frame: at Day 7 ]
    CCTA or CAG will be used to evaluate the RA graft outcome at Day 7 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.

  2. the rate of RA graft failure at Day 168 [ Time Frame: at Day 168 ]
    CCTA or CAG will be used to evaluate the RA graft outcome at Day 168 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.


Secondary Outcome Measures :
  1. the time to first Major Adverse Cardiovascular Events (MACE) [ Time Frame: during the study period (168 days) ]
    MACE will include all-cause death, myocardial infarction, stroke and unplanned revascularization.

  2. the proportion of subjects with angina recurrence [ Time Frame: during the study period (168 days) ]
    The angina symptoms will be evaluated by Canadian Cardiovascular Society angina grade and Seattle Angina Questionnaires.

  3. the proportion of subjects with at least one hypotension occurrence [ Time Frame: during the study period (168 days) ]
    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.

  4. the proportion of subjects with ACEI/ARB/ARNI withdrawal [ Time Frame: during the study period (168 days) ]
    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.

  5. the proportion of subjects with serious adverse events (SAEs) and concerned adverse events (AEs) [ Time Frame: during the study period (168 days) ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04310995


Contacts
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Contact: Qiang Zhao, MD.PhD +8613701695256 zq11607@rjh.com.cn
Contact: Yunpeng Zhu, MD +8613816819346 zyp12220@rjh.com.cn

Locations
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China
Ruijin Hospital Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, China, 200025
Contact: Yunpeng Zhu, MD.    +8613816819346    zyp12220@rjh.com.cn   
Sponsors and Collaborators
Ruijin Hospital
Chugai Pharma China
Investigators
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Principal Investigator: Qiang Zhao, MD.PhD Ruijin Hospital
Study Director: Yunpeng Zhu, MD Ruijin Hospital
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Responsible Party: Qiang Zhao,MD, Vice President of RuijinHospital, Professor and Director, Department of Cardiac Surgery, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT04310995    
Other Study ID Numbers: SIG-IIS001C
First Posted: March 17, 2020    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Qiang Zhao,MD, Ruijin Hospital:
CABG
Radial artery grafts
Antispastic
Nicorandil
Diltiazem
Isosorbide Mononitrate
Additional relevant MeSH terms:
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Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Nicorandil
Diltiazem
Isosorbide
Isosorbide Dinitrate
Isosorbide-5-mononitrate
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Nitric Oxide Donors
Anti-Arrhythmia Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances