NCT02294643

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P50-P75 for phase_3 coronary-artery-disease

Timeline
Completed

Started Apr 2009

Typical duration for phase_3 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 19, 2014

Completed
Last Updated

November 25, 2014

Status Verified

November 1, 2014

Enrollment Period

2.9 years

First QC Date

November 10, 2014

Last Update Submit

November 24, 2014

Conditions

Coronary Artery DiseaseDiabetes MellitusRenal Insufficiency, Chronic

Keywords

sarpogrelate

Outcome Measures

Primary Outcomes (1)

  • late lumen loss measured by quantitative coronary angiography

    9 months

Secondary Outcomes (7)

  • all cause deaths

    12 months

  • cardiac death

    12 months

  • nonfatal myocardial infraction

    12 months

  • target lesion revascularization

    12 months

  • major bleeding using the TMI bleeding classification

    12 months

  • +2 more secondary outcomes

Study Arms (2)

aspirin, clopidogrel & sarpogrelate

ACTIVE COMPARATOR

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

Drug: SarpogrelateDrug: AspirinDrug: Clopidogrel

aspirin, clopidogrel & placebo

PLACEBO COMPARATOR

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

Drug: AspirinDrug: ClopidogrelDrug: Placebo (for Sarpogrelate)

Interventions

SarpogrelateDRUG
Also known as: Anplag
aspirin, clopidogrel & sarpogrelate
AspirinDRUG
Also known as: Astrix, Aspirin protect
aspirin, clopidogrel & placeboaspirin, clopidogrel & sarpogrelate
ClopidogrelDRUG
Also known as: Plavix
aspirin, clopidogrel & placeboaspirin, clopidogrel & sarpogrelate
Placebo (for Sarpogrelate)DRUG
Also known as: sugar pill manufactured to mimic sarpogrelate tablet
aspirin, clopidogrel & placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • if they had contraindication to aspirin, clopidogrel or sarpogrelate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, 463-707, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 35224730DERIVED

  • 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.

    PMID: 25891091DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseDiabetes MellitusRenal Insufficiency, Chronic

Interventions

sarpogrelateAspirinClopidogrelSugars

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTiclopidineThienopyridinesThiophenesSulfur CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCarbohydrates

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Cardiovascular Center in Seoul National University Bundang Hospital

Study Record Dates

First Submitted

November 10, 2014

First Posted

November 19, 2014

Study Start

April 1, 2009

Primary Completion

March 1, 2012

Study Completion

March 1, 2014

Last Updated

November 25, 2014

Record last verified: 2014-11

Locations

KR(1)