The impact of Ticagrelor and Clopidogrel on the Index of Myocardial Resistence (IMR)

Phase 1

• Conditions: Patients with ST segment elevation myocardial infarction; MedDRA version: 21.1 Level: PT Classification code 10053460 Term: Antiplatelet therapy System Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0 Level: PT Classification code 10000891 Term: Acute myocardial infarction System Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-001277-14-GB
• Lead Sponsor: Royal Papworth Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-17
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 140

Inclusion Criteria

For inclusion in the study subjects should fulfill the following 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. Any STEMI (ST elevation = 2mm in contiguous chest leads) with chest pain symptom onset < 24 hours

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
1. Cardiogenic shock
2. Previous myocardial infarction in the infarct-related artery requiring intervention
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 to the IMP
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. Known Moderate or Severe hepatic impairment or abnormal liver function tests (ALT >5x ULN) at baseline (if available)
10. Severe asthma that has required hospital admission or significant bradycardia/ complete heart block diagnosed on ECG (contraindications to
adenosine).
11. Severe co-morbidity with a life expectancy < 3 months.
12. Women of child bearing age unless confirmed by direct questioning that they are reproductively sterile or post-menopausal.
13. Concomitant treatment with anticoagulants.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified