This study has been transitioned to CTIS with ID 2022-502140-13-00 check the CTIS register for the current data. 1. To compare bleeding risk (i.e. safety) with DAPT compared to standard therapy during the first 30 days following PCI/ACS in patients…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary safety endpoint: International Society for Thrombosis and Haemostatis
(ISTH) major + clinically relevant non-major bleeding (CRNMB) at 30 days
Primary efficacy endpoint: composite endpoint of all-cause death, MI, stroke,
systemic embolism, stent thrombosis) at 30 days
Secondary outcome
Secondary endpoints: separate components of primary endpoints, net clinical
benefit, quality of life.
Background summary
A central issue in patients with atrial fibrillation (AF) and coronary artery
disease (CAD) is to find the optimal balance between ischemic and bleeding
risk. Combination therapy with OAC and DAPT (triple therapy) is associated with
high risk of major bleeding. Omitting aspirin (dual therapy) reduces bleeding,
but meta-analysis found increased risk of myocardial infarction and stent
thrombosis in the first month after PCI with this strategy. In this study we
propose a strategy of DAPT with temporary withdrawal of OAC during the first 30
days following PCI or ACS versus standard therapy (edoxaban and P2Y12
inhibitor).
Study objective
This study has been transitioned to CTIS with ID 2022-502140-13-00 check the CTIS register for the current data.
1. To compare bleeding risk (i.e. safety) with DAPT compared to standard
therapy during the first 30 days following PCI/ACS in patients with AF
2. To compare ischemic risk (i.e. efficacy) with DAPT compared to standard
therapy during the first 30 days following PCI/ACS in patients with AF
Study design
Multicentre open-label randomized controlled trial.
The safety endpoint will be analysed for superiority; the efficacy endpoint
will be analysed for non-inferiority.
Intervention
Random (1:1) allocation to one month of DAPT following PCI/ACS versus standard
therapy (edoxaban + P2Y12 inhibitor, and aspirin usually limited to admission).
After one month all patients will be treated with edoxaban and P2Y12 inhibitor
until 6 months after randomization.
Study burden and risks
See section E9
Koekoekslaan 1
Nieuwegein 3435CM
NL
Koekoekslaan 1
Nieuwegein 3435CM
NL
Listed location countries
Age
Inclusion criteria
1. >=18 years of age
2. Undergoing PCI or presenting with ACS with elevated cardiac markers
(CK/CK-MB, troponin)
3. History of or newly diagnosed atrial fibrillation or flutter with a
long-term (>= 1 year) indication for OAC
Exclusion criteria
1. Contra indication to edoxaban
2. < 3 months after any stroke
3. < 3 months after venous thrombo embolism
4. Mechanical heart valve prosthesis
5. Moderate to severe mitral valve stenosis
6. Intracardiac thrombus
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2022-502140-13-00 |
| EudraCT | EUCTR2022-001298-30-NL |
| ClinicalTrials.gov | NCT04436978 |
| CCMO | NL81102.100.22 |