TIMES: Ticagrelor vs. Placebo/ Clopidogrel With Aspirin in Anterior STEMI Patients Treated With Primary PCI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-30

Study Completion Date

2019-11-30

Brief Summary

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This is a single-centred, double blind randomized controlled trial comparing ticagrelor with placebo in clopidogrel and aspirin loaded patients.

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Detailed Description

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The very early benefit of ticagrelor in STEMI is co-mediated by adenosine cardioprotection maintaining/ improving myocardial microcirculatory function, as well as via platelet inhibition or possibly other pleiotropic effects.

Ticagrelor increases circulating adenosine by reducing cellular re-uptake. Adenosine is a cardioprotective agent that utilizes cellular survival kinase pathways that may have beneficial effects on the microcirculation and myocardium in patients presenting with STEMI. Adenosine is currently used as a treatment for no-reflow and improves MVO post-STEMI when administered during PPCI. A recent study of healthy volunteers has confirmed that non-invasive coronary flow is augmented by ticagrelor and that this is mediated by adenosine. The Investigators propose that the very early beneficial effects of Ticagrelor in ACS may be adenosine mediated cardioprotection, rather than only due to an antiplatelet effect. This important research is original and a natural progression of the ticagrelor story. It expands the adenosine hypothesis and mode of action of ticagrelor and addresses a novel cardioprotective/ microcirculatory mechanism of action.

Conditions

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ST Elevation Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Double blind until the point of primary endpoint.

Study Groups

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Ticagrelor

Patients will receive Ticagrelor 180mg (2 x 90mg tablets)

Group Type EXPERIMENTAL

Ticagrelor

Intervention Type DRUG

2 x 90mg Ticagrelor tablets

Placebo

Patients will receive Placebo (2 matching tablets)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

2 x matching placebo tablets

Interventions

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Ticagrelor

2 x 90mg Ticagrelor tablets

Intervention Type DRUG

Placebo

2 x matching placebo tablets

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Provision of informed verbal consent prior to any study specific procedures taking place with written consent confirmed prior to in-patient cardiac MRI.
2. Male or female adult patient aged 18 - 90 years old
3. Anterior STEMI (ST elevation ≥ 2mmHg in contiguous chest leads) with chest pain symptom onset \< 12 hours

Exclusion Criteria

1. Cardiogenic shock\*
2. Previous anterior myocardial infarction
3. Unfavourable coronary anatomy for PCI: left main / surgical or distal coronary disease
4. Already prescribed Ticagrelor at the time of admission
5. Factors affecting study drug administration/ absorption: vomiting or allergy
6. Concomitant use of potent CYP3A4 inhibitors/ inducers (e.g ketoconazole and rifampicin) or CYP3A4 substrates with a narrow therapeutic window (e.g. cisapride and ergot alkaloids) or simvastatin / lovostatin \>40mg oral dose.
7. Severe bleeding diathesis or current active bleeding\*
8. History of intracranial haemorrhage
9. Moderate or Severe hepatic impairment
10. Severe asthma or bradycardia/ complete heart block (contraindications to adenosine)\*
11. Severe co-morbidity with a life expectancy \< 3 months.
12. Women of child bearing potential (as determined by direct questioning of the patient to confirm and this will be documented in the medical notes).

* Patients that are found to have any excluding factor (e.g., unfavourable coronary anatomy for PCI) or develop any excluding factor (e.g., vomiting or cardiogenic shock) before the point of final IMR assessment will be discontinued from the study and followed up at discharge and by telephone at 3 and 12 months for adverse event monitoring purposes only.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No