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
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
oral Nicorandil 5mg (Tablets) three times daily for 168 days
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Qiang Zhao, MD.PhDemail@example.com|
|Contact: Yunpeng Zhu, MDfirstname.lastname@example.org|
|Ruijin Hospital Shanghai Jiaotong University School of Medicine||Recruiting|
|Shanghai, China, 200025|
|Contact: Yunpeng Zhu, MD. +8613816819346 email@example.com|
|Principal Investigator:||Qiang Zhao, MD.PhD||Ruijin Hospital|
|Study Director:||Yunpeng Zhu, MD||Ruijin Hospital|