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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

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Diabetes Mellitus Renal Insufficiency, Chronic Drug: Sarpogrelate Drug: Aspirin Drug: Clopidogrel Drug: Placebo (for Sarpogrelate) Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : April 2009
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: Sarpogrelate
Other Name: Anplag

Drug: Aspirin
Other Names:
  • Astrix
  • Aspirin protect

Drug: Clopidogrel
Other Name: Plavix

Placebo Comparator: aspirin, clopidogrel & placebo
the dual anti-platelet group will receive aspirin 100mg and clopidogrel 75mg daily plus placebo twice daily
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




Primary Outcome Measures :
  1. late lumen loss measured by quantitative coronary angiography [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. all cause deaths [ Time Frame: 12 months ]
  2. cardiac death [ Time Frame: 12 months ]
  3. nonfatal myocardial infraction [ Time Frame: 12 months ]
  4. target lesion revascularization [ Time Frame: 12 months ]
  5. major bleeding using the TMI bleeding classification [ Time Frame: 12 months ]
  6. 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

  7. renal impairments as measured by increased microalbuminuria or decreased creatinine clearance [ Time Frame: 12 months ]
    increased microalbuminuria or decreased creatinine clearance



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02294643


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Yuhan Corporation

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dong-Ju Choi, Chief of Cardiovascular Center in Seoul National University Bundang Hospital, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT02294643     History of Changes
Other Study ID Numbers: SERENADE trial
First Posted: November 19, 2014    Key Record Dates
Last Update Posted: November 25, 2014
Last Verified: November 2014

Keywords provided by Dong-Ju Choi, Seoul National University Bundang Hospital:
sarpogrelate

Additional relevant MeSH terms:
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Myocardial Ischemia
Aspirin
Clopidogrel
Diabetes Mellitus
Coronary Artery Disease
Coronary Disease
Renal Insufficiency
Renal Insufficiency, Chronic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Kidney Diseases
Urologic Diseases
Sarpogrelate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action