Short-term efficacy and safety of low-dose ticagrelor in acute coronary syndrome patients with high bleeding risk

Not Applicable

Completed

• Conditions: Diseases of the circulatory system

• Registration Number: KCT0004640
• Lead Sponsor: Pusan National University Hospital

Brief Summary

Bleeding episodes were most commonly observed at 1month and then decreased over time. Compared with standard-dose ticagrelor, half-dose ticagrelor did not reduce total bleeding (BARC type 1-5) during 6month (odds ratio(OR) 0.900, 95% confidence interval [CI] 0.563-1.440, p=0.661). However, serious bleeding events (BARC type =2) occurred less often in half-dose ticagrelor (OR 0.284, 95% CI 0.088-0.921, p=0.036). Likewise, the overall rate of moderate-to-severe dyspnoea was highest at 1 month, then decreased over time. Half-dose ticagrelor did not decrease the rate of any dyspnoeaor moderate-to-severe dyspnoea during 6month. The risk of ischemic events was also similar between the groups.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-09-18
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

Acute Coronary Syndrome
Patients who have completed a successful cardiovascular perfusion procedure
PRU <90 patients
Patients who voluntarily signed a research agreement

Exclusion Criteria

1. Patients unable to take ticagrelor (severe chronic obstructive pulmonary disease, history of cerebral hemorrhage)
2. Patients with multi-vascular disease and coronary artery bypass surgery
3. Moderate-Those with severe liver disease
4. Those who have bradycardia symptoms such as same-sex bradycardia and atrioventricular conduction block
5. Those with respiratory distress, such as those with chronic obstructive pulmonary disease.
6. Pregnant or lactating women
7. Those who have undergone hemodialysis or peritoneal dialysis due to end stage renal failure and have undergone kidney transplantation
8. A person who, due to other reasons, judges that participation in a clinical trial is inappropriate.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BARC bleeding

Secondary Outcome Measures

Name	Time	Method
platelet reactivity unit by VerifyNow;Borg Dyspnea scale;MACCE(CV death, MI, stroke), major bleeding