None listed
Conditions
Brief summary
The Ticagrelor in Coronary microvascular dysfunction (TIC) program is an extensive research program investigating the potential therapeutic benefits of ticagrelor in patients with a condition referred as slow flow phenomenon, speculating that its benefits extend beyond its anti-platelet effects and suggesting that it may have an important role in the management of these patients. Ticagrelor has been developed as an anti- platelet agent and is currently utilised in the management of heart attack and unstable angina. Slow flow means heart muscle does not receive blood quickly enough and as a consequence patient may experience chest pain. Medical treatment is directed towards controlling the angina pain. Taking Ticagrelor orally twice a day, which has the ability to relax the small microscopic blood vessels in the heart, may lead to better blood flow to the heart muscle and reduce the associated symptoms of chest pain. However, at present, there is no scientific evidence available demonstrating how effective ticagrelor is in patients with slow flow. The aim of this study is to investigate whether taking ticagrelor (90mg twice daily for 4 weeks) can reduce frequency of chest pain in these slow flow patients.
Interventions
Oral administration comprising the dose of 90mg Ticagrelor or Placebo twice daily for a total period of 8 weeks (4 weeks each) to assess the effect of ticagrelor on angina frequency in patients with Coronary Slow Flow who experience angina at least 3 times/week.
After the first 4 weeks (Phase 1) completed, two weeks washout period is allowed, patients will not need to take any study tablets specifically for this trial in the washout period.
The investigational product will be packed in bottle
Oral administration comprising the dose of 90mg Ticagrelor or Placebo twice daily for a total period of 8 weeks (4 weeks each) to assess the effect of ticagrelor on angina frequency in patients with Coronary Slow Flow who experience angina at least 3 times/week. After the first 4 weeks (Phase 1) completed, two weeks washout period is allowed, patients will not need to take any study tablets specifically for this trial in the washout period. The investigational product will be packed in bottle covering the period from one visit to the next. Each patient will receive and return the designated bottle at the regular site visits.
Sponsors
University of Adelaide
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For inclusion in the study subjects should fulfill the following criteria: I. Provision of informed consent prior to any study specific procedures II. Female and/or male patients aged greater than or equal to 18 years III. Documented angiographic features of coronary slow flow. as defined by TIMI-2 flow (i.e. requiring more than 3 beats to opacify a major epicardial vessel) in the absence of obstructive coronary artery disease (i.e. no epicardial lesion greater than 50%). IV. Chest pain occurring more than or equal to 3 times/week in the preceding two weeks.
Exclusion criteria
Subjects should not enter the study if any of the following exclusion criteria are fulfilled: I. Acute coronary syndrome admission within the preceding month; i.e. hospital admission for prolonged rest associated with new ischaemic ECG changes and/or a troponin rise. II. Secondary causes of coronary slow flow including - the no-reflow phenomenon and myocarditis. III. Secondary causes of angina including - clinically significant anaemia (haemoglobin less than 100g/dL), uncontrolled atrial fibrillation (i.e. ventricular response rate greater than 108 bpm), haemodynamically significant aortic stenosis (estimated mean aortic valve gradient equal to 50mmHg). Exclusions from contraindications of Consumer Medical Information BRILINTA (Registered Trademark) ticagrelor product information Doc ID-001619899 v4.0 IV. Patients taking regular Aspirin, non-steroidal anti-inflammatory drugs and oral coagulants. V. Patients scheduled for any surgeries
Outcome results
None listed