Coronary Artery Disease, Diabetes Mellitus, Renal Insufficiency, Chronic
Conditions
Keywords
sarpogrelate
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.
Interventions
Sponsors
Yuhan Corporation
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| late lumen loss measured by quantitative coronary angiography | 9 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cardiac death | 12 months | — |
| nonfatal myocardial infraction | 12 months | — |
| target lesion revascularization | 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 |
| major bleeding using the TMI bleeding classification | 12 months | — |
Countries
South Korea
Outcome results
None listed