Coronary Artery Disease Clinical Trial
Official title:
A Multicenter Randomized Trial Evaluating the Efficacy of Sarpogrelate on Ischemic Heart Disease After Drug-eluting Stent Implantation in Patients With Diabetes Mellitus or Renal Impairment
The purpose of the SERENADE trial is to evaluate the safety and efficacy of sarpogrelate in patients with CKD or DM after DES implantation.
The rates of stent failure after percutaneous intervention (PCI) have declined after
introduction of the drug eluting stent (DES). However, chronic kidney disease (CKD) or
diabetes mellitus (DM) still remains a strong clinical predictor of poor prognosis with DES.
Sarpogrelate, a selective 5-HT2a receptor antagonist, has antiproliferative effects as shown
by its reduction of neointimal hyperplasia and smooth muscle cell proliferation as well as a
potent antiplatelet agent inhibiting of 5-HT-induced platelet aggregation. However, the
efficacy and safety data for sarpogrelate in patients with CKD or DM are limited. We aimed
to test whether sarpogrelate has beneficial effects in patients with CDK or DM treated with
DES.
The SERENADE trial is a multicenter, off-label, prospective, placebo-controlled randomized
study to test the superiority of triple anti-platelet therapy (TAT; aspirin, clopidogrel and
sarpogrelate) to the 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 exhibiting coronary artery disease (CAD) with DM or CKD will be
randomized to TAT or DAT (1:1 ratio) after DES implantation. Primary endpoint is late lumen
loss at 9 months assessed by quantitative coronary angiography (QCA). Secondary efficacy
endpoints are composites of major adverse cardiovascular events (MACE) including cardiac
death, nonfatal myocardial infarction (MI), and target lesion revascularization. Secondary
safety endpoints are major bleeding event and hepatic or renal impairments.
The SERENADE trial will give insight whether adjunctive therapy with sarpogrelate is helpful
for patients with high risk profiles such as CKD or DM after DES implantation.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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