TIMES: Ticagrelor vs. Placebo/ Clopidogrel With Aspirin in Anterior STEMI Patients Treated With Primary PCI
A Randomised Mechanistic Study Comparing the Effects of Different Anti-platelet Combinations (Ticagrelor vs. Placebo/ Clopidogrel) With Aspirin in Patients Presenting With Anterior STEMI Treated With Primary PCI
1 other identifier
interventional
140
1 country
1
Brief Summary
This is a single-centred, double blind randomized controlled trial comparing ticagrelor with placebo in clopidogrel and aspirin loaded patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2017
Typical duration for phase_2
1 active site
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
Study Start
First participant enrolled
January 30, 2017
CompletedFirst Submitted
Initial submission to the registry
April 13, 2017
CompletedFirst Posted
Study publicly available on registry
May 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2019
CompletedMay 30, 2017
May 1, 2017
1.8 years
April 13, 2017
May 25, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Index of Myocardial Resistance (IMR)
To compare final Index of Myocardial Resistance (IMR) at the end of the PPCI procedure between the two arms.
Baseline to end of PPCI procedure.
Secondary Outcomes (7)
Baseline IMR and change in IMR during PPCI
Baseline to end of PPCI procedure.
ACF and AMR pre/post PPCI
Baseline to end of PPCI procedure.
TIMI flow and TMBG pre/post PPCI
Baseline to end of PPCI procedure.
ST segment resolution
Baseline to end of PPCI procedure.
OCT quantified clot volume pre/post PPCI
Baseline to end of PPCI procedure.
- +2 more secondary outcomes
Other Outcomes (5)
Creatinine levels (eGRF) at 0, 12 and 24 hours
Baseline to 24 hours.
NYHA Functional Classification and CCS Angina Grading Scale
Discharge to 12 months.
Plasma Ticagrelor levels at the point of final IMR measurement and in-patient Cardiac MRI.
End of PPCI procedure to 24-48 hours.
- +2 more other outcomes
Study Arms (2)
Ticagrelor
EXPERIMENTALPatients will receive Ticagrelor 180mg (2 x 90mg tablets)
Placebo
PLACEBO COMPARATORPatients will receive Placebo (2 matching tablets)
Interventions
Eligibility Criteria
You may qualify if:
- Provision of informed verbal consent prior to any study specific procedures taking place with written consent confirmed prior to in-patient cardiac MRI.
- Male or female adult patient aged 18 - 90 years old
- Anterior STEMI (ST elevation ≥ 2mmHg in contiguous chest leads) with chest pain symptom onset \< 12 hours
You may not qualify if:
- Cardiogenic shock\*
- Previous anterior myocardial infarction
- Unfavourable coronary anatomy for PCI: left main / surgical or distal coronary disease
- Already prescribed Ticagrelor at the time of admission
- Factors affecting study drug administration/ absorption: vomiting or allergy
- 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.
- Severe bleeding diathesis or current active bleeding\*
- History of intracranial haemorrhage
- Moderate or Severe hepatic impairment
- Severe asthma or bradycardia/ complete heart block (contraindications to adenosine)\*
- Severe co-morbidity with a life expectancy \< 3 months.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Papworth Hospital NHS Foundation Trustlead
- AstraZenecacollaborator
Study Sites (1)
Papworth Hospital NHS Foundation Trust
Papworth Everard, Cambridge, CB23 3RE, United Kingdom
Related Publications (1)
Aetesam-Ur-Rahman M, Brown AJ, Jaworski C, Giblett JP, Zhao TX, Braganza DM, Clarke SC, Agrawal BSK, Bennett MR, West NEJ, Hoole SP. Adenosine-Induced Coronary Steal Is Observed in Patients Presenting With ST-Segment-Elevation Myocardial Infarction. J Am Heart Assoc. 2021 Jul 6;10(13):e019899. doi: 10.1161/JAHA.120.019899. Epub 2021 Jun 30.
PMID: 34187187DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Hoole
Papworth Hospital NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Double blind until the point of primary endpoint.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2017
First Posted
May 9, 2017
Study Start
January 30, 2017
Primary Completion
November 30, 2018
Study Completion
November 30, 2019
Last Updated
May 30, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share