Risk of bleeding after dual antiplatelet therapy (DAPT) in patients treated with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)

Not Applicable

Completed

• Conditions: Acute coronary syndrome; Circulatory System

• Registration Number: ISRCTN76607611
• Lead Sponsor: niversity of Bristol (UK)

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35961692/ Patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) (added 15/08/2022) 2023 Results article in https://doi.org/10.3310/mnjy9014 (added 13/07/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-19
• Study Completion: 2019-05-31
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 21961

Inclusion Criteria

Patients will be included if they:
1. Are labelled as ‘acceptable’ for use in research by CPRD (a process that identifies and excludes patients with non-continuous follow up or patients with poor data recording that raises suspicion as to the validity of that patient’s record)
2. Are over 18 years of age
3. Have one year of medical history in CPRD before cohort entry (time of index procedure or event)
4. Have a record of aspirin monotherapy (Asp) or dual antiplatelet therapy (DAPT: aspirin and clopidogrel, AC; aspirin and prasugrel, AP; aspirin and ticagrelor, AT) in the year following the index procedure or event
5. No record of DAPT in the 3 month prior to the index procedure or event

Exclusion Criteria

Participants will excluded if they do not meet the above inclusion criteria

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bleeding event (classified as minor or major by WHO bleeding scale) <br><br>These are all time to event outcomes, so duration of follow up will be time from index event (PCI, CABG or ACS event) to: date of first bleeding event (mortality, hospital admission for the secondary outcomes); 12 months after entry into the cohort (i.e. we will stop following people up if they had no event after 12 months); date of the end of period covered by the data extraction if this is less than 12 months after entry into the cohort; last date of continuous exposure to DAPT + 2 weeks to account for drug clearance (we will consider exposure to be continuous if < 2 weeks between repeat prescriptions); loss of follow up from CPRD.<br><br>We will also identify all bleeding events during follow-up (12 months)

Secondary Outcome Measures

Name	Time	Method
1. All-cause mortality<br>2. Cardiovascular mortality<br>3. Mortality from bleeding<br>4. Hospital admission<br><br>These are all time to event outcomes, so duration of follow up will be time from index event (PCI, CABG or ACS event) to: date of first bleeding event (mortality, hospital admission for the secondary outcomes); 12 months after entry into the cohort (i.e. we will stop following people up if they had no event after 12 months); date of the end of period covered by the data extraction if this is less than 12 months after entry into the cohort; last date of continuous exposure to DAPT + 2 weeks to account for drug clearance (we will consider exposure to be continuous if < 2 weeks between repeat prescriptions); loss of follow up from CPRD.