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

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ClinicalTrials.gov Identifier: NCT02294643
Recruitment Status : Completed
First Posted : November 19, 2014
Last Update Posted : November 25, 2014
Sponsor:
Collaborator:
Yuhan Corporation
Information provided by (Responsible Party):
Dong-Ju Choi, Seoul National University Bundang Hospital

Tracking Information
First Submitted Date  ICMJE November 10, 2014
First Posted Date  ICMJE November 19, 2014
Last Update Posted Date November 25, 2014
Study Start Date  ICMJE April 2009
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2014)
late lumen loss measured by quantitative coronary angiography [ Time Frame: 9 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02294643 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2014)
  • all cause deaths [ Time Frame: 12 months ]
  • cardiac death [ Time Frame: 12 months ]
  • nonfatal myocardial infraction [ Time Frame: 12 months ]
  • target lesion revascularization [ Time Frame: 12 months ]
  • major bleeding using the TMI bleeding classification [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 months ]
    increased microalbuminuria or decreased creatinine clearance
Original Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2014)
  • all cause deaths [ Time Frame: 12 months ]
  • cardiac death [ Time Frame: 12 months ]
  • nonfatal myocardial infraction [ Time Frame: 12 months ]
  • target lesion revascularization [ Time Frame: 12 months ]
  • major bleeding using the TMI bleeding classification [ Time Frame: 12 months ]
  • hepatic impairments [ Time Frame: 12 months ]
  • renal impairments [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Design of 'Influence of Sarpogrelate in Patients With Renal Impairment or Diabetes Mellitus' Study
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Coronary Artery Disease
  • Diabetes Mellitus
  • Renal Insufficiency, Chronic
Intervention  ICMJE
  • Drug: Sarpogrelate
    Other Name: Anplag
  • Drug: Aspirin
    Other Names:
    • Astrix
    • Aspirin protect
  • Drug: Clopidogrel
    Other Name: Plavix
  • Drug: Placebo (for Sarpogrelate)
    Other Name: sugar pill manufactured to mimic sarpogrelate tablet
Study Arms  ICMJE
  • Active Comparator: 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
    Interventions:
    • Drug: Sarpogrelate
    • Drug: Aspirin
    • Drug: Clopidogrel
  • Placebo Comparator: aspirin, clopidogrel & placebo
    the dual anti-platelet group will receive aspirin 100mg and clopidogrel 75mg daily plus placebo twice daily
    Interventions:
    • Drug: Aspirin
    • Drug: Clopidogrel
    • Drug: Placebo (for Sarpogrelate)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 14, 2014)
220
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE Not Provided
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02294643
Other Study ID Numbers  ICMJE SERENADE trial
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dong-Ju Choi, Seoul National University Bundang Hospital
Study Sponsor  ICMJE Seoul National University Bundang Hospital
Collaborators  ICMJE Yuhan Corporation
Investigators  ICMJE Not Provided
PRS Account Seoul National University Bundang Hospital
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP