ISAR-DAPT (A Comparative Evaluation of Efficacy and Safety in the 3-Months DAPT Group vs. the 6-Months DAPT Group of Patients Treated With the Coroflex ISAR Stent; A Prospective, Multicenter, Randomized, Open-Label Clinical Trial)

November 18, 2015 updated by: Myeong-Ho Yoon, Ajou University School of Medicine

A Comparative Evaluation of Efficacy and Safety in the 3-Months DAPT Group vs. the 6-Months DAPT Group of Patients Treated With the Coroflex ISAR Stent; A Prospective, Multicenter, Randomized, Open-Label Clinical Trial

This clinical trial studies patients treated with the Coroflex ISAR Stent for coronary artery disease in order for the objective of verifying the non-inferiority of results that among patients who were administered DAPT for 3 months compared to patients who were administered DAPT for 6 months, in terms of the efficacy and safety of DAPT.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

906

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Suwon
      • Yeongtong-gu, Suwon, Korea, Republic of, 16499
        • Recruiting
        • Ajou University Hospital
        • Contact:
          • Myeong-Ho Yoon, Ph.D, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients aged 19 or older
  2. Patients who have submitted a written consent to participate in the clinical trial
  3. De novo lesion
  4. Patients scheduled for elective intervention to treat ischemic cardiovascular disease

Exclusion Criteria:

  1. Patients with any contraindications or hypersensitivity related to antiplatelet therapy
  2. Patients with Acute Myocardial Infarction (ST elevation myocardial infarction, Non ST elevation myocardial infarction)
  3. Patients who are anticipated to receive treatment or surgery that may require desisting the administration of antiplatelet therapy for 2 weeks or longer during the period of the clinical trial
  4. Chronic total occlusion (CTO) lesions, in-stent restenosis (ISR)
  5. Patients experiencing cardiogenic shock
  6. Women who are breastfeeding, pregnant, or desiring pregnancy
  7. Patients with findings of hemorrhage
  8. Patients with a life expectancy of less than 1 year
  9. Patients who have received a drug-eluting stent (DES) procedure within the past 6 months
  10. Any other patients judged by the investigator to be unsuitable for the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Coroflex ISAR 3 months DAPT
Patients who have received a Coroflex ISAR stent procedure to treat coronary arterial lesions, and administered the drug for 3 months
Device: Coroflex ISAR
This stent platform has a thin-strut cobalt-chromiun alloy backbone, no polymer, microporous surface.
Drug: 3 months DAPT
Other Names:
  • Aspirin + clopidogrel for 3-months schedule after the coronary stenting
ACTIVE_COMPARATOR: Coroflex ISAR 6 months DAPT
Patients who have received a Coroflex ISAR stent procedure to treat coronary arterial lesions, and administered the drug for 6 months
Device: Coroflex ISAR
This stent platform has a thin-strut cobalt-chromiun alloy backbone, no polymer, microporous surface.
Drug: 6 months DAPT
Other Names:
  • Aspirin + clopidogrel for 6-months schedule after the coronary stenting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE
Time Frame: 12 months from the time of the stenting
Major Adverse Cardiac Events (MACE) (cardiac death, recurrent myocardial infarction, target lesion revascularization) at 12 months from the time of the procedure
12 months from the time of the stenting

Secondary Outcome Measures

Outcome Measure
Time Frame
MACE
Time Frame: 6 months from the time of the stenting
6 months from the time of the stenting
Any death, cardiac death, MI, TLR, TVR
Time Frame: 6 months from the time of the stenting
6 months from the time of the stenting
Any death, cardiac death, MI, Stroke, TLR, TVR
Time Frame: 12 months from the time of the stenting
12 months from the time of the stenting

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ajou University School of Medicine

Collaborators

B. Braun Korea Co., Ltd.

Investigators

  • Principal Investigator: Myeong-Ho Yoon, Ph.D, MD, Cardiovascular Center, Ajou University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

June 1, 2019

Study Registration Dates

First Submitted

November 18, 2015

First Submitted That Met QC Criteria

November 18, 2015

First Posted (ESTIMATE)

November 20, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

November 20, 2015

Last Update Submitted That Met QC Criteria

November 18, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AJOU-CV-0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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