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

Phase 4

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: Ticagrelor; Drug: Clopidogrel

• Registration Number: NCT02792712
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-05-18
• Status Verified: 2016-06
• Study First Submitted QC: 2016-06-01
• Last Update Submitted: 2016-06-01
• Study First Posted: 2016-06-07
• Last Update Posted: 2016-06-07
• Primary Completion: 2018-01
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STEMI_MRI_Ticagrelor	Ticagrelor	A Magnetic Resonance Imaging Study in myocardial salvage in patients with ST-Elevation myocardial infarction (STEMI) undergoing pRimary percutaneous coronary intervention - Ticagrelor Arm
STEMI_MRI_Clopidogrel	Clopidogrel	A Magnetic Resonance Imaging Study in myocardial salvage in patients with ST-Elevation myocardial infarction (STEMI) undergoing pRimary percutaneous coronary intervention - Clopidogrel Arm

Primary Outcome Measures

Name	Time	Method
Compare myocardial infarct size (myocardial salvage index %) as assessed by CE-MRI between 300-mg clopidogrel group and 180-mg ticargrelor group	4-10 days after the index event

Trial Locations

Locations (1)

Teipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan