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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)

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ClinicalTrials.gov Identifier: NCT02609698
Recruitment Status : Recruiting
First Posted : November 20, 2015
Last Update Posted : November 20, 2015
Sponsor:
Collaborator:
B. Braun Korea Co., Ltd.
Information provided by (Responsible Party):
Myeong-Ho Yoon, Ajou University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Stable Angina, Unstable Angina, Silent Coronary Ischemia, Coronary Artery Disease Device: Coroflex ISAR Drug: 3 months DAPT Drug: 6 months DAPT Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 906 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

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 Name: 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 Name: Aspirin + clopidogrel for 6-months schedule after the coronary stenting




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. MACE [ Time Frame: 6 months from the time of the stenting ]
  2. Any death, cardiac death, MI, TLR, TVR [ Time Frame: 6 months from the time of the stenting ]
  3. Any death, cardiac death, MI, Stroke, TLR, TVR [ Time Frame: 12 months from the time of the stenting ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02609698


Contacts
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Contact: Myeong-Ho Yoon, Ph.D, MD +82-31-219-4329 yoonmh65@hanmail.net,

Locations
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Korea, Republic of
Ajou University Hospital Recruiting
Yeongtong-gu, Suwon, Korea, Republic of, 16499
Contact: Myeong-Ho Yoon, Ph.D, MD         
Sponsors and Collaborators
Ajou University School of Medicine
B. Braun Korea Co., Ltd.
Investigators
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Principal Investigator: Myeong-Ho Yoon, Ph.D, MD Cardiovascular Center, Ajou University Hospital

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Responsible Party: Myeong-Ho Yoon, Professor, Dept of Cardiology, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT02609698     History of Changes
Other Study ID Numbers: AJOU-CV-0001
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015

Keywords provided by Myeong-Ho Yoon, Ajou University School of Medicine:
Stent
Polymer-free
Antiplatelet therapy
Clopidogrel
DES
DAPT

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Angina, Stable
Angina, Unstable
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Aspirin
Clopidogrel
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