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

NCT02792712 | Unknown Phase 4

• 1 other identifier: 2014-09-003A
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Keywords

Acute myocardial infarction; Antiplatelet agents; Magnetic resonance imaging (MRI)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

STEMI_MRI_Ticagrelor

EXPERIMENTAL

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

STEMI_MRI_Clopidogrel

ACTIVE COMPARATOR

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

Interventions

Ticagrelor DRUG

Ticagrelor 180 mg LD，then 90 mg BID

STEMI_MRI_Ticagrelor

Clopidogrel DRUG

Clopidogrel 300 mg LD，then 75 mg QD

STEMI_MRI_Clopidogrel

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent prior to any study specific procedures
• Adult patients aged 20 years or older
• 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.
• STEMI patients planned for PPCI

You may not qualify if:

• STEMI \> 12 h of onset
• History of renal dysfunction requiring dialysis
• Evidence of malignant diseases
• Unwillingness to give out consent
• Contraindicated for ticagrelor or clopidogrel

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Teipei Veterans General Hospital

Taipei, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Ticagrelor; Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Tao-Cheng Wu, MD, PhD.

CONTACT

(02)28712121; dcwu@vghtpe.gov.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tao-Cheng Wu, MD, PhD, Division of Cardiology, Department of Medicine

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: June 7, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: June 7, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)