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Study design of the influence of SErotonin inhibition on patients with RENAl impairment or diabetes undergoing drug-eluting stent implantation (SERENADE) study: A multicenter, open-label, prospective, randomized study
- Source :
- Contemporary Clinical Trials. 43:20-24
- Publication Year :
- 2015
- Publisher :
- Elsevier BV, 2015.
-
Abstract
- Background The rates of stent failure after percutaneous coronary intervention have decreased since the introduction of the drug-eluting stent (DES). However, chronic kidney disease (CKD) and diabetes mellitus (DM) remain strong clinical predictors of poor prognosis despite DES implantation. Sarpogrelate, a selective serotonin (5-hydroxytryptamine (HT)2a [5-HT2A]) receptor antagonist, has antiproliferative effects, reducing neointimal hyperplasia and smooth muscle cell proliferation, as well as potent antiplatelet action, inhibiting 5-HT-induced platelet aggregation. However, efficacy and safety data for sarpogrelate in patients with CKD or DM are limited. We aim to determine whether sarpogrelate has beneficial effects in patients with CDK or DM treated with DES implantation. Methods/design The SERENADE trial is a multicenter, open-label, prospective, randomized study that will test the superiority of triple anti-platelet therapy (TAT; aspirin, clopidogrel, and sarpogrelate) to conventional dual antiplatelet therapy (DAT; aspirin and clopidogrel) in preventing late lumen loss 9 months after the index procedure in patients with CKD or DM. A total of 220 patients diagnosed with coronary artery disease with DM or CKD will be randomized to the TAT or DAT groups (1:1 ratio) after DES implantation. The primary endpoint is late lumen loss at 9 months assessed by quantitative coronary angiography. Secondary efficacy endpoints are composites of major adverse cardiovascular events including cardiac death, nonfatal myocardial infarction, and target lesion revascularization. Secondary safety endpoints are major bleeding events and hepatic or renal impairment. Discussion The SERENADE trial will provide insight on the efficacy of adjunctive therapy with sarpogrelate after DES implantation for patients with high-risk profiles such as CKD or DM. Trial registration National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov NCT02294643).
- Subjects :
- Male
medicine.medical_specialty
Ticlopidine
medicine.medical_treatment
Urology
Hemorrhage
Sarpogrelate
Coronary Angiography
Coronary Restenosis
Coronary artery disease
chemistry.chemical_compound
Percutaneous Coronary Intervention
Republic of Korea
Diabetes Mellitus
medicine
Clinical endpoint
Hepatic Insufficiency
Humans
Pharmacology (medical)
Prospective Studies
Renal Insufficiency, Chronic
Aspirin
business.industry
Percutaneous coronary intervention
Stent
Drug-Eluting Stents
Succinates
General Medicine
medicine.disease
Clopidogrel
Surgery
chemistry
Research Design
Drug-eluting stent
Drug Therapy, Combination
Female
Serotonin Antagonists
business
Platelet Aggregation Inhibitors
Kidney disease
medicine.drug
Subjects
Details
- ISSN :
- 15517144
- Volume :
- 43
- Database :
- OpenAIRE
- Journal :
- Contemporary Clinical Trials
- Accession number :
- edsair.doi.dedup.....2575ab443848a9e4956c08bafe7b7e36