NCT02607436

Brief Summary

This is a prospective interventional study to assess the effect of sarpogrelate compared with aspirin in Korean type 2 diabetic patients with atherosclerosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_4 coronary-artery-disease

Timeline
Completed

Started Jul 2015

Shorter than P25 for phase_4 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

July 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 18, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 3, 2016

Status Verified

May 1, 2016

Enrollment Period

7 months

First QC Date

November 12, 2015

Last Update Submit

May 2, 2016

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Coronary artery disease assessed by cardiac computed tomography angiography

    6 months

Secondary Outcomes (8)

  • Coronary artery calcium score assessed by cardiac computed tomography angiography

    6 months

  • Coronary artery stenosis assessed by cardiac computed tomography angiography

    6 months

  • Changes of plaque size assessed by cardiac computed tomography angiography

    6 months

  • Changes of plaque composition assessed by cardiac computed tomography angiography

    6 months

  • Changes of Ankle-branchial index

    6 months

  • +3 more secondary outcomes

Study Arms (2)

Sarpogrelate + Aspirin

EXPERIMENTAL

Sarpogrelate as an active drug

Drug: SarpogrelateDrug: Aspirin

Aspirin alone

ACTIVE COMPARATOR

Aspirin as an active comparator

Drug: Aspirin

Interventions

SarpogrelateDRUG

Sarpogrelate

Also known as: Anplag
Sarpogrelate + Aspirin
AspirinDRUG

Aspirin

Also known as: Aspirin protect or Astrix
Aspirin aloneSarpogrelate + Aspirin

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes with HbA1c ≥ 6.5% at screening visit
  • Male or female between 30 and 80 years of age
  • Coronary artery stenosis: 10-75% without no evidence of acute coronary syndrome
  • No history of previous myocardial infarction

You may not qualify if:

  • Systolic blood pressure / diastolic blood pressure \> 160/110 mmHg
  • Congestive heart failure
  • Allergy to radiocontrast dye
  • Allergy to aspirin or sarpogrelate
  • Acute bleeding
  • History of ulcer bleeding
  • GOT/GPT \> 100/100
  • Other antiplatelet medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

sarpogrelateAspirin

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Soo Lim, MD, PhD

    SNUBH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 12, 2015

First Posted

November 18, 2015

Study Start

July 1, 2015

Primary Completion

February 1, 2016

Study Completion

April 1, 2016

Last Updated

May 3, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)