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Modify the trial design and construct a new larger trial.
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The goal of this clinical trial is to to evaluate the effect of oral isosorbide mononitrate plus amlodipine antispasm therapy on outcomes of radial artery grafts in patients underwent primary isolated CABG.
The main question it aims to answer is:
Whether the oral isosorbide mononitrate plus amlodipine antispasm therapy could reduce the failure outcome of radial artery grafts after CABG .
Researchers will compare isosorbide mononitrate plus amlodipine to none to see if isosorbide mononitrate plus amlodipine works.
Participants will
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isosorbide Mononitrate + Amlodipine | Experimental | Oral isosorbide mononitrate 40mg (if unable to tolerate, use 20mg) once daily + amlodipine 5mg (if unable to tolerate, use 2.5mg) once daily for 24 weeks after CABG |
|
| Blank control | No Intervention | no use of any nitrates or CCBs for 24 weeks after CABG. if there are indications of hypertension, use RAASi rather than CCB. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral isosorbide mononitrate 4+ amlodipine | Drug | Oral isosorbide mononitrate 40mg (if unable to tolerate, 20mg) once daily + amlodipine 5mg (if unable to tolerate, 2.5mg) once daily for 24 weeks after CABG |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of RA graft failure at Week 24 | A protocol-driven CCTA will be used to evaluate the RA graft outcome at Week 24 after CABG. Fitzgibbon Grade B/S/O is definned as Graft Failure. | at Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| The time to first Major Adverse Cardiovascular Event (MACE) | MACE is a composite of all-cause death, myocardial infarction(including peri-operative MI and silent MI), stroke and unplanned revascularization. | within 24 weeks |
| The proportion of participants with at least once symptomatic hypotension |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qiang Zhao, MD | Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China | Principal Investigator |
| Mario FL Gaudino, MD | Weill Cornell Medicine NewYork Presbyterian Hospital, NY, US | Principal Investigator |
| Yunpeng Zhu, MD | Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital Shanghai Jiao Tong University School of Medicine | Shanghai | China |
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| within 24 weeks |