Clinical trial NCT02294643: Study Design of 'Influence of Sarpogrelate in Patients With Renal Impairment or Diabetes Mellitus' Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Diabetes Mellitus
Renal Insufficiency, Chronic
Keywords: sarpogrelate
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: Yuhan Corporation
First posted: 2014-11-19
Enrollment: 220
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the SERENADE trial is to evaluate the safety and efficacy of sarpogrelate in patients with CKD or DM after DES implantation.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* symptomatic CAD (including acute coronary syndrome) or positive stress test and a native coronary lesion (\>50% diameter stenosis by visual estimation on coronary angiogram and reference diameter \> 2.5 mm)
* AND CKD or DM patients

Exclusion Criteria:

* if they had contraindication to aspirin, clopidogrel or sarpogrelate.

Primary outcomes:
measure: late lumen loss measured by quantitative coronary angiography
timeFrame: 9 months
Secondary outcomes:
measure: all cause deaths
timeFrame: 12 months
measure: cardiac death
timeFrame: 12 months
measure: nonfatal myocardial infraction
timeFrame: 12 months
measure: target lesion revascularization
timeFrame: 12 months
measure: major bleeding using the TMI bleeding classification
timeFrame: 12 months
measure: hepatic impairments as measured by ncreased serum glutamyl oxaloacetic transaminase level or glutamyl pyruvic transaminase level increased more than threefold of the upper normal range
timeFrame: 12 months
measure: renal impairments as measured by increased microalbuminuria or decreased creatinine clearance
timeFrame: 12 months
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
References:
citation: Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
citation: Lee SA, Suh JW, Park JJ, Yoon CH, Cho YS, Youn TJ, Chae IH, Kim HS, Kim SH, Choi DJ. 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. Contemp Clin Trials. 2015 Jul;43:20-4. doi: 10.1016/j.cct.2015.04.005. Epub 2015 Apr 16.