Anti-anginal Efficacy of Ticagrelor in Coronary Slow Flow
The University of AdelaideDataset description
The CSFP is an angiographic finding characterised by the delayed passage of contrast through the coronary arteries, despite the absence of obstructive coronary artery disease (defined as less than 50% narrowing of the vessel lumen). Ticagrelor may serve as an effective anti-anginal therapy for these patients by increasing adenosine levels, which could alleviate coronary microvascular dysfunction and its associated angina due to its vasodilatory properties.
This study is designed as a double-blind, placebo controlled, crossover study, to assess the effect of ticagrelor 90mg bd on angina frequency in patients with the Coronary Slow Flow Phenomenon (CSFP) who experience angina at least 3 times/week.
This asset includes data evaluating the anti-anginal efficacy of a 4-week ticagrelor therapy regimen in 20 CSFP patients with refractory angina. The mean age of patients 61.5 ± 10.5 years and 40% were women. Additionally, the asset includes the trial primary endpoint, which was the frequency of angina episodes, recorded using an angina diary. Secondary endpoints include the duration and severity of angina episodes, consumption of short-acting nitrates, and health status evaluations using the Seattle Angina Questionnaire (SAQ) and the Short Form-36 (SF-36) indices.
Results from the data asset are publicly available in an open-access publication: https://www.mdpi.com/2077-0383/13/17/5235
Requests in relation to this data asset should be made to the corresponding author. The data are not publicly available due to privacy and ethical restrictions.
Date Information
Identifiers
Source Study
Trial name (public)
Purpose:
Phase:
Trial acronym
Not available
Trial ID
ACTRN12616000388415
Funding
Commercial sector/Industry, AstraZeneca Pty Ltd
Scientific enquiries
Ms Sivabaskari Pasupathy
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 .... Read more
Key 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 occurrin .... Read more
Key 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 fibrill .... Read more
Can healthy volunteers participate?
No
Population
Sample Size 24
Min. age 18 Years
Max. age No limit
Sex Both males and females
Condition category Coronary Slow Flow Phenomenon
Condition code Cardiovascular
Intervention
Intervention code Treatment: Drugs
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 co .... Read more
Comparison
Control group Placebo
This study is designed as a double-blind, placebo controlled, crossover study. Placebo drug will involve taking a drug (for 4 weeks) that looks similar in appearance to Ticagrelor but will not affect the patient in any way. Placebo consists of lactose monohydrate, microcrystalline cellulose, and magnesium stearate. The composition of the film- coat is identical to that of the corresponding strength of ticagrelor active tablets.
Outcomes
Outcome: To assess the effect of ticagrelor 90mg bd on angina frequency in patients with Coronary Slow Flow who experience angina at least 3 times/week. Patients will maintain an angina diary throughout this study period. This diary will describe the frequency and characteristics of chest pain (i.e. the time of day, severity, triggers, etc.). In addition, we will administer Seattle Angina Questionnaire (SAQ) at screening and at the end of each phases. Timepoint: Before th .... Read more