Clinical trial NCT02792712: Ticagrelor Versus Clopidogrel in Myocardial Salvage in Patients With STEMI Undergoing Primary PCI
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Keywords: Acute myocardial infarction
Antiplatelet agents
Magnetic resonance imaging (MRI)
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2016-06-07
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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.

Eligibility 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

Primary outcomes:
measure: Compare myocardial infarct size (myocardial salvage index %) as assessed by CE-MRI between 300-mg clopidogrel group and 180-mg ticargrelor group
timeFrame: 4-10 days after the index event
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Teipei Veterans General Hospital
Study officials:
References: