Efficacy Study of Nicorandil on Neointima
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|ClinicalTrials.gov Identifier: NCT02328521|
Recruitment Status : Unknown
Verified January 2015 by Zhang Ying Qian, Chinese PLA General Hospital.
Recruitment status was: Recruiting
First Posted : December 31, 2014
Last Update Posted : January 21, 2015
|Condition or disease||Intervention/treatment||Phase|
|Angina, Unstable Diabetes Mellitus||Drug: Nicorandil Drug: nicorandil placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Efficacy Study of Nicorandil on Neointima After Coronary Drug-eluting Stent Implantation in Patients With Diabetic Mellitus|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||July 2016|
Experimental: Nicorandil group
Drug: Nicorandil (Chugai Pharmaceutical Co, Japan). The first dose is given 8h before selective percutaneous coronary intervention, 10mg, oral. After the percutaneous coronary intervention, nicorandil is given for 30 days, 5mg each time, 3 times daily oral.
Nicorandil is given once before PCI and given 3 times daily for 30 days after PCI.
Other Name: Sigmart
Placebo Comparator: Control group
Drug: Nicorandil placebo (Sihuan Pharmaceutical Co, China). The first dose is given 8h before selective percutaneous coronary intervention, 2 tablets, oral. After the percutaneous coronary intervention, placebo is given for 30 days, 1 tablet each time, 3 times daily oral.
Drug: nicorandil placebo
Nicorandil placebo is given once before PCI and given 3 times daily for 30 days after PCI.
Other Name: no other names
- Neointimal thickness (in μm) [ Time Frame: 9 month ]Neointimal thickness is defined as the distance between the stent strut and lumen surface.
- Neointimal area [ Time Frame: 9 month ]Stent and lumen areas will be measured, and neointimal area is calculated as stent area minus lumen area.
- number of uncovered stent struts [ Time Frame: 9 month ]
- percent of uncovered stent struts [ Time Frame: 9 month ]
- characteristics of neointima (number of homogenous neointimal,number of layered neointima, number of heterogeneous neointima) [ Time Frame: 9 month ]The characteristics of neointimal hyperplasia will be assessed and classified into three patterns according to the neointimal signal intensity.
- number of in-stent neoatherosclerosis [ Time Frame: 9 month ]
- angiographic late lumen loss (in mm) [ Time Frame: 9 month ]Late lumen loss is the difference of baseline and follow-up minimal luminal diameters.
- rate of restenosis (in %) [ Time Frame: 9 month ]
- number of major adverse cardiovascular events [ Time Frame: 9 month ]
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): NCT02328521
|Contact: Ying Qian Zhang, M.D.||firstname.lastname@example.org|
|Chinese PLA General Hospital||Recruiting|
|Beijing, Beijing, China, 100853|
|Contact: Yundai Chen, M.D. 86-010-55499309 email@example.com|
|Principal Investigator:||Yundai Chen, M.D.||Chinese PLA General Hospital|