Anti-anginal Efficacy of Ticagrelor in Coronary Slow Flow.

Phase 4

• Conditions: Coronary Slow Flow Phenomenon; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12616000388415
• Lead Sponsor: niversity of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-24
• Study Completion: 2021-12-07
• Last Update Posted: 28 March 2022

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br>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. [Before the administration of any drug : For 2 weeks using the angina diary and SAQ<br>Medication phase 1 : For 4 weeks using the angina diary<br>At the end of Phase 1: SAQ<br>Washout period : For 2 weeks using the angina diary<br>Medication phase 2 (cross over) : For 4 weeks using the angina diary<br>At the end of Phase 2: SAQ<br><br><br>]