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

NCT ID: NCT02294643

Last Updated: 2014-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2014-03-31

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.

Conditions

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Coronary Artery Disease Diabetes Mellitus Renal Insufficiency, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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aspirin, clopidogrel & sarpogrelate

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

Group Type ACTIVE_COMPARATOR

Sarpogrelate

Intervention Type DRUG

Aspirin

Intervention Type DRUG

Clopidogrel

Intervention Type DRUG

aspirin, clopidogrel & placebo

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

Group Type PLACEBO_COMPARATOR

Aspirin

Intervention Type DRUG

Clopidogrel

Intervention Type DRUG

Placebo (for Sarpogrelate)

Intervention Type DRUG

Interventions

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Sarpogrelate

Intervention Type DRUG

Aspirin

Intervention Type DRUG

Clopidogrel

Intervention Type DRUG

Placebo (for Sarpogrelate)

Intervention Type DRUG

Other Intervention Names

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Anplag Astrix Aspirin protect Plavix sugar pill manufactured to mimic sarpogrelate tablet

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.
Minimum Eligible Age

18 Years

Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Yuhan Corporation

INDUSTRY

Sponsor Role collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dong-Ju Choi

Chief of Cardiovascular Center in Seoul National University Bundang Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 35224730 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25891091 (View on PubMed)

Other Identifiers

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SERENADE trial

Identifier Type: -

Identifier Source: org_study_id