Study Design of 'Influence of Sarpogrelate in Patients With Renal Impairment or Diabetes Mellitus' Study

Phase 3

Completed

• Conditions: Diabetes Mellitus; Renal Insufficiency, Chronic; Coronary Artery Disease
• Interventions: Drug: Sarpogrelate; Drug: Aspirin; Drug: Clopidogrel; Drug: Placebo (for Sarpogrelate)

• Registration Number: NCT02294643
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2012-03
• Study Completion: 2014-03
• Status Verified: 2014-11
• Study First Submitted: 2014-11-10
• Study First Submitted QC: 2014-11-14
• Study First Posted: 2014-11-19
• Last Update Submitted: 2014-11-24
• Last Update Posted: 2014-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aspirin, clopidogrel & sarpogrelate	Sarpogrelate	the triple anti-platelet treatment group will receive aspirin 100mg, clopidogrel 75mg and sarpogrelate (Anplag®, Yuhan Corporation, Seoul, South Korea) 100mg twice daily
aspirin, clopidogrel & placebo	Placebo (for Sarpogrelate)	the dual anti-platelet group will receive aspirin 100mg and clopidogrel 75mg daily plus placebo twice daily
aspirin, clopidogrel & sarpogrelate	Aspirin	the triple anti-platelet treatment group will receive aspirin 100mg, clopidogrel 75mg and sarpogrelate (Anplag®, Yuhan Corporation, Seoul, South Korea) 100mg twice daily
aspirin, clopidogrel & placebo	Clopidogrel	the dual anti-platelet group will receive aspirin 100mg and clopidogrel 75mg daily plus placebo twice daily
aspirin, clopidogrel & placebo	Aspirin	the dual anti-platelet group will receive aspirin 100mg and clopidogrel 75mg daily plus placebo twice daily
aspirin, clopidogrel & sarpogrelate	Clopidogrel	the triple anti-platelet treatment group will receive aspirin 100mg, clopidogrel 75mg and sarpogrelate (Anplag®, Yuhan Corporation, Seoul, South Korea) 100mg twice daily

Primary Outcome Measures

Name	Time	Method
late lumen loss measured by quantitative coronary angiography	9 months

Secondary Outcome Measures

Name	Time	Method
cardiac death	12 months
all cause deaths	12 months
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	12 months	increased serum glutamyl oxaloacetic transaminase level or glutamyl pyruvic transaminase level increased more than threefold of the upper normal range
renal impairments as measured by increased microalbuminuria or decreased creatinine clearance	12 months	increased microalbuminuria or decreased creatinine clearance
nonfatal myocardial infraction	12 months
major bleeding using the TMI bleeding classification	12 months
target lesion revascularization	12 months

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of