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Trial record 63 of 1050 for:    clopidogrel

Ticagrelor Versus Clopidogrel in Myocardial Salvage in Patients With STEMI Undergoing Primary PCI

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ClinicalTrials.gov Identifier: NCT02792712
Recruitment Status : Unknown
Verified June 2016 by vghtpe user, Taipei Veterans General Hospital, Taiwan.
Recruitment status was:  Recruiting
First Posted : June 7, 2016
Last Update Posted : June 7, 2016
Sponsor:
Information provided by (Responsible Party):
vghtpe user, Taipei Veterans General Hospital, Taiwan

Brief Summary:
Therefore, in this study, we try to evaluate the impact of clopidogrel loading dose 300mg vs. ticagrelor 180 mg on myocardial injury as measured by contrast-enhanced magnetic resonance imaging (CE-MRI) in STEMI patients undergoing primary PCI.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Drug: Ticagrelor Drug: Clopidogrel Phase 4

Detailed Description:

All STEMI patients will be loaded with dual oral antiplatelet therapy of 300 mg aspirin combined with either 300 mg clopidogrel or 180 mg ticagrelor before PCI, followed by maintenance dose of 100 mg aspirin plus 75 mg clopidogrel QD or 90 mg ticagrelor BID. The duty interventional cardiologists will be responsible for patient randomization based on a pre-defined randomization chart. As it is a usual practice in Taiwan for door-to-balloon time to be within 90 minutes, we hence do not expect any impact on study results due to D2B time variation.

All STEMI patients will receive loading dose of dual oral antiplatelet therapy with 300 mg aspirin combined with either 300 mg clopidogrel or 180 mg ticagrelor before PCI, followed by maintenance dose of 100 mg aspirin plus 75 mg clopidogrel QD or 90 mg ticagrelor BID.

The primary variable is to compare myocardial salvage index (in %) as assessed by CE-MRI between 300-mg clopidogrel group and ticargrelor group. Enzymatic infarct size will also be assessed, and two methods will be used to decide that. The first is cardiac troponinI 72 hours after pain onset , while the other is peak CK level after pain onset. Sampling timing of CK will be judged by the caring physicians.

The secondary objectives include: myocardial infarct size (% of LV mass), the extent of MVO, the number of segments with >75% of infarct transmurality.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Ticagrelor Versus Clopidogrel in Myocardial Salvage in Patients With ST-elevation Myocardial Infarction (STEMI) Undergoing Primary Percutaneous Coronary Intervention: A Magnetic Resonance Imaging Study (TIGER Study)
Study Start Date : January 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: STEMI_MRI_Ticagrelor
A Magnetic Resonance Imaging Study in myocardial salvage in patients with ST-Elevation myocardial infarction (STEMI) undergoing pRimary percutaneous coronary intervention - Ticagrelor Arm
Drug: Ticagrelor
Ticagrelor 180 mg LD,then 90 mg BID

Active Comparator: STEMI_MRI_Clopidogrel
A Magnetic Resonance Imaging Study in myocardial salvage in patients with ST-Elevation myocardial infarction (STEMI) undergoing pRimary percutaneous coronary intervention - Clopidogrel Arm
Drug: Clopidogrel
Clopidogrel 300 mg LD,then 75 mg QD




Primary Outcome Measures :
  1. Compare myocardial infarct size (myocardial salvage index %) as assessed by CE-MRI between 300-mg clopidogrel group and 180-mg ticargrelor group [ Time Frame: 4-10 days after the index event ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of informed consent prior to any study specific procedures
  2. Adult patients aged 20 years or older
  3. STEMI within 12 hours of onset, defined as:presence of chest pain for >30 minutes and <12 hours after symptom onset; ST-segment elevation >1 mm in ≥2 contiguous leads or presumably a new-onset left bundle-branch block on electrocardiogram.
  4. STEMI patients planned for PPCI

Exclusion Criteria:

  1. STEMI > 12 h of onset
  2. History of renal dysfunction requiring dialysis
  3. Evidence of malignant diseases
  4. Unwillingness to give out consent
  5. Contraindicated for ticagrelor or clopidogrel

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): NCT02792712


Contacts
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Contact: Tao-Cheng Wu, MD, PhD. (02)28712121 ext 3793 dcwu@vghtpe.gov.tw

Locations
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Taiwan
Teipei Veterans General Hospital Recruiting
Taipei, Taiwan, 112
Contact: Tao-Cheng Wu, MD, PhD    +886-2-28712121 ext 3655    dcwu@vghtpe.gov.tw   
Principal Investigator: Tao-Cheng Wu, MD, PhD         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan

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Responsible Party: vghtpe user, Tao-Cheng Wu, MD, PhD, Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT02792712     History of Changes
Other Study ID Numbers: 2014-09-003A
First Posted: June 7, 2016    Key Record Dates
Last Update Posted: June 7, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by vghtpe user, Taipei Veterans General Hospital, Taiwan:
Acute myocardial infarction
Antiplatelet agents
Magnetic resonance imaging (MRI)
Additional relevant MeSH terms:
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Clopidogrel
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs