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)

NCT02609698 | Unknown Phase 4

• 1 other identifier: AJOU-CV-0001
• Study Type: interventional
• Target: 906
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stable Angina, Unstable Angina, Silent Coronary Ischemia, Coronary Artery Disease

Keywords

Stent; Polymer-free; Antiplatelet therapy; Clopidogrel; DES; DAPT

Outcome Measures

Primary Outcomes (1)

• MACE

  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 Outcomes (3)

• MACE

  6 months from the time of the stenting

• Any death, cardiac death, MI, TLR, TVR

  6 months from the time of the stenting

• Any death, cardiac death, MI, Stroke, TLR, TVR

  12 months from the time of the stenting

Study Arms (2)

Coroflex ISAR 3 months DAPT

EXPERIMENTAL

Patients who have received a Coroflex ISAR stent procedure to treat coronary arterial lesions, and administered the drug for 3 months

Device: Coroflex ISAR; Drug: 3 months DAPT

Coroflex ISAR 6 months DAPT

ACTIVE COMPARATOR

Patients who have received a Coroflex ISAR stent procedure to treat coronary arterial lesions, and administered the drug for 6 months

Device: Coroflex ISAR; Drug: 6 months DAPT

Interventions

Coroflex ISAR DEVICE

This stent platform has a thin-strut cobalt-chromiun alloy backbone, no polymer, microporous surface.

Coroflex ISAR 3 months DAPT; Coroflex ISAR 6 months DAPT

3 months DAPT DRUG

Also known as: Aspirin + clopidogrel for 3-months schedule after the coronary stenting

Coroflex ISAR 3 months DAPT

6 months DAPT DRUG

Also known as: Aspirin + clopidogrel for 6-months schedule after the coronary stenting

Coroflex ISAR 6 months DAPT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with any contraindications or hypersensitivity related to antiplatelet therapy
• Patients with Acute Myocardial Infarction (ST elevation myocardial infarction, Non ST elevation myocardial infarction)
• 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
• Chronic total occlusion (CTO) lesions, in-stent restenosis (ISR)
• Patients experiencing cardiogenic shock
• Women who are breastfeeding, pregnant, or desiring pregnancy
• Patients with findings of hemorrhage
• Patients with a life expectancy of less than 1 year
• Patients who have received a drug-eluting stent (DES) procedure within the past 6 months
• Any other patients judged by the investigator to be unsuitable for the trial

Sponsors & Collaborators

• Ajou University School of Medicine: lead
• B. Braun Korea Co., Ltd.: collaborator

Study Sites (1)

Ajou University Hospital

Yeongtong-gu, Suwon, 16499, South Korea

RECRUITING

Related Publications (1)

• Jin U, Seo KW, Yang HM, Lim HS, Choi BJ, Choi SY, Shin JH, Tahk SJ, Yoo SY, Rha SW, Chung WY, Kim CH, Won KB, Pyun WB, Jang JS, Lee SY, Hong YJ, Kim MH, Hong SJ, Choi YS, Kim HY, Choi RK, Kang WC, Cho EJ, Yoon MH. Efficacy and Safety of 3 Versus 6 Months of Dual-Antiplatelet Therapy in Patients Implanted With a Coroflex ISAR Stents: A Prospective, Multicenter, Randomized Clinical Trial. J Invasive Cardiol. 2022 Sep;34(9):E653-E659. doi: 10.25270/jic/21.00330. Epub 2022 Jul 22.

  PMID: 35863061 DERIVED

MeSH Terms

Conditions

Angina, Stable; Angina, Unstable; Coronary Artery Disease

Interventions

2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosine; Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Myeong-Ho Yoon, Ph.D, MD

  Cardiovascular Center, Ajou University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Myeong-Ho Yoon, Ph.D, MD

CONTACT

+82-31-219-4329; yoonmh65@hanmail.net,

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: Professor, Dept of Cardiology

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: November 20, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: June 1, 2019
• Last Updated: November 20, 2015

Record last verified: 2015-11

Locations

KR (1)