title: 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.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov NCT02294643).
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
authors.forename: Seung-Ah
authors.initials: SA
authors.lastname: Lee
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
authors.forename: Jung-Won
authors.initials: JW
authors.lastname: Suh
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
authors.forename: Jin Joo
authors.initials: JJ
authors.lastname: Park
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
authors.forename: Chang-Hwan
authors.initials: CH
authors.lastname: Yoon
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
authors.forename: Young-Suk
authors.initials: YS
authors.lastname: Cho
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
authors.forename: Tae-Jin
authors.initials: TJ
authors.lastname: Youn
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
authors.forename: In-Ho
authors.initials: IH
authors.lastname: Chae
authors.affiliation: Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.
authors.forename: Hyo-Soo
authors.initials: HS
authors.lastname: Kim
authors.affiliation: Seoul National University Boramae Medical Center, Seoul, Republic of Korea.
authors.forename: Sang-Hyun
authors.initials: SH
authors.lastname: Kim
authors.affiliation: Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea. Electronic address: djchoi@snubh.org.
authors.forename: Dong-Ju
authors.initials: DJ
authors.lastname: Choi
mesh_terms: D001241:Aspirin / Q000008:administration & dosage; D000077144:Clopidogrel; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000517:prevention & control*; D003920:Diabetes Mellitus / Q000453:epidemiology* / Q000503:physiopathology; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D048550:Hepatic Insufficiency / Q000139:chemically induced; D006801:Humans; D008297:Male; D062645:Percutaneous Coronary Intervention / Q000379:methods; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D051436:Renal Insufficiency, Chronic / Q000453:epidemiology*; D056910:Republic of Korea; D012107:Research Design; D012702:Serotonin Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D013386:Succinates / Q000008:administration & dosage* / Q000009:adverse effects; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives
chemical_list: D010975:Platelet Aggregation Inhibitors; D012702:Serotonin Antagonists; D013386:Succinates; C064294:sarpogrelate; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin
keywords: Chronic kidney disease; Clinical trial; Diabetes melitus; Drug eluting stent; Randomized controlled trial