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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Coronary Artery Disease, Diabetes Mellitus, Renal Insufficiency, Chronic

Intervention / Treatment
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* Drug: Sarpogrelate
* Drug: Aspirin
* Drug: Clopidogrel
* Drug: Placebo (for Sarpogrelate)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years


Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: aspirin, clopidogrel & sarpogrelate<br>the triple anti-platelet treatment group will receive aspirin 100mg, clopidogrel 75mg and sarpogrelate (Anplag®, Yuhan Corporation, Seoul, South Korea) 100mg twice daily | Drug: Sarpogrelate<br> <br> * Other names: Anplag;Drug: Aspirin<br> <br> * Other names: Aspirin protect;Drug: Clopidogrel<br> <br> * Other names: Plavix;|
| Placebo Comparator: aspirin, clopidogrel & placebo<br>the dual anti-platelet group will receive aspirin 100mg and clopidogrel 75mg daily plus placebo twice daily | Drug: Aspirin<br> <br> * Other names: Aspirin protect;Drug: Clopidogrel<br> <br> * Other names: Plavix;Drug: Placebo (for Sarpogrelate)<br> <br> * Other names: sugar pill manufactured to mimic sarpogrelate tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| late lumen loss measured by quantitative coronary angiography |  | 9 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sarpogrelate