NCT02507323

Brief Summary

This study has been designed as a randomized, double-blind trial to provide definitive evidence on the effects of ticagrelor and prasugrel on myocardial salvage in patients with anterior ST Segment Elevation Myocardial Infarction (STEMI) undergoing primary Percutaneous Coronary Intervention (PCI). This study will also measure the effects of ticagrelor vs. prasugrel on secondary endpoints listed above. This study design aims to test the hypothesis that ticagrelor will reduce myocardial infarct size as a proportion of the ischemic area at risk when compared to prasugrel.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 23, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

May 4, 2016

Status Verified

May 1, 2016

Enrollment Period

1.5 years

First QC Date

July 17, 2015

Last Update Submit

May 3, 2016

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • Efficacy as measured by infarct size on all randomized patients.

    up to Day 90

Secondary Outcomes (1)

  • Safety as measured by incidences of treatment emergent adverse events, serious adverse events, treatment-related adverse events and adverse events leading to stop of drug

    90 days

Study Arms (2)

ticagrelor or matching placebo

ACTIVE COMPARATOR

ticagrelor (180 mg loading followed by 90 mg twice daily) or matching placebo

Drug: ticagrelorDrug: Placebo

prasugrel or matching placebo

ACTIVE COMPARATOR

prasugrel (60 mg loading followed by 5-10 mg/d) or matching placebo

Drug: prasugrelDrug: Placebo

Interventions

ticagrelorDRUG

A platelet aggregation inhibitor

Also known as: Brilinta
ticagrelor or matching placebo
prasugrelDRUG

a thienopyridine class inhibitor of platelet activation and aggregation

Also known as: Effient
prasugrel or matching placebo
PlaceboDRUG

placebo

prasugrel or matching placeboticagrelor or matching placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent: Signed informed consent prior to any study specific procedures
  • Age: Male and females aged 18 years and older
  • Onset: Presenting to emergency room or cardiac catheterization laboratory within 6 hours of onset of myocardial infarction symptoms
  • Continuing to have ongoing myocardial infarction symptoms
  • EKG findings: ST elevation on ECG with positive T waves in the precordial leads, suggestive of anterior STEMI
  • Triaged for emergency cardiac catheterization (primary PCI protocol)
  • Agree to use an effective contraceptive method beginning at the signing of the informed consent and for at least 30 days after the last dose of study drug. The definition of an effective method of contraception will be based on the judgment of the investigator.

You may not qualify if:

  • Prior myocardial infarction
  • Contraindication to ticagrelor and/or prasugrel
  • Contraindication to gadolinium
  • Contraindication to aspirin
  • Treatment with fibrinolytic therapy for the index STEMI
  • High risk of bleeding
  • Presenting with cardiogenic shock
  • Infarction due to stent thrombosis
  • History of a previous coronary artery bypass graft (CABG)
  • Known renal insufficiency (acute kidney injury or Glomerular Filtration Rate \< 40 mL/min/1.73 m2).
  • Moderate or severe hepatic impairment
  • Inability to undergo cardiac MRI
  • Indication for aspirin \>162 mg/d
  • Indication for Nonsteroidal Anti-Inflammatory Drugs or COX2 inhibitors
  • Pregnant
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Baylor-St. Lukes Medical Center

Houston, Texas, 77030, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

TicagrelorPrasugrel Hydrochloride

Intervention Hierarchy (Ancestors)

AdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesThiophenesSulfur CompoundsOrganic ChemicalsPiperazinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Yochai Birnbaum, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 17, 2015

First Posted

July 23, 2015

Study Start

February 1, 2016

Primary Completion

August 1, 2017

Study Completion

November 1, 2017

Last Updated

May 4, 2016

Record last verified: 2016-05

Locations

US(3)