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

Seoul National University

Status and phase

Completed

Phase 3

Conditions

Coronary Artery Disease

Diabetes Mellitus

Renal Insufficiency, Chronic

Treatments

Drug: Clopidogrel

Drug: Placebo (for Sarpogrelate)

Drug: Aspirin

Drug: Sarpogrelate

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02294643

SERENADE trial

Details and patient eligibility

About

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

Full 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.

Enrollment

220 patients

Sex

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

220 participants in 2 patient groups, including a placebo group

aspirin, clopidogrel & sarpogrelate

Active Comparator group

Description:

the triple anti-platelet treatment group will receive aspirin 100mg, clopidogrel 75mg and sarpogrelate (Anplag®, Yuhan Corporation, Seoul, South Korea) 100mg twice daily

Treatment:

Drug: Aspirin

Drug: Sarpogrelate

Drug: Clopidogrel

aspirin, clopidogrel & placebo

Placebo Comparator group

Description:

the dual anti-platelet group will receive aspirin 100mg and clopidogrel 75mg daily plus placebo twice daily

Treatment:

Drug: Aspirin

Drug: Placebo (for Sarpogrelate)

Drug: Clopidogrel