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

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

Tracking Information

• First Submitted Date: November 10, 2014
• First Posted Date: November 19, 2014
• Last Update Posted Date: November 25, 2014
• Study Start Date: April 2009
• Actual Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 14, 2014): late lumen loss measured by quantitative coronary angiography [ Time Frame: 9 months ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT02294643 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (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 (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: Study Design of 'Influence of Sarpogrelate in Patients With Renal Impairment or Diabetes Mellitus' Study
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

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

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 14, 2014): 220
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: March 2014
• Actual Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

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: Not Provided
• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT02294643
• Other Study ID Numbers: SERENADE trial
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dong-Ju Choi, Seoul National University Bundang Hospital
• Study Sponsor: Seoul National University Bundang Hospital
• Collaborators: Yuhan Corporation
• Investigators: Not Provided
• PRS Account: Seoul National University Bundang Hospital
• Verification Date: November 2014