1. To investigate the efficacy of dual therapy (omitting acetylsalicylic acid) compared to triple therapy in patients with atrial fibrillation and acute coronary syndrome.2. To investigate the safety of dual therapy (omitting acetylsalicylic acid)…
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
- Coronary artery disorders
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary efficacy endpoint: composed endpoint of all-cause death, MI, stroke,
systemic embolism, stent thrombosis.
Primary safety endpoint: ISTH major + clinically relevant non-major bleeding.
Secondary outcome
Secondary endpoints: separate components of primary endpoints, net clinical
benefit, quality of life.
Background summary
Patients with atrial fibrillation presenting with acute coronary syndrome have
an indication for both oral anticoagulation (OAC) and dual antiplatelet therapy
(DAPT). This triple therapy (OAC + DAPT) is associated with increased bleeding
risk. Several RCTs have proven dual therapy (OAC + P2Y12 inhibitor) to reduce
this bleeding risk compared to triple therapy without significant difference in
efficacy (i.e. [CV-]death, stroke, recurrent MI, stent thrombosis, systemic
embolism). However, none of this studies did focus on ACS patients, which are
at higher thrombotic risk than patients with stable coronary artery disease.
Also, none of these studies were statistically powered for efficacy,
withholding the practice guidelines to change their recommendations.
Study objective
1. To investigate the efficacy of dual therapy (omitting acetylsalicylic acid)
compared to triple therapy in patients with atrial fibrillation and acute
coronary syndrome.
2. To investigate the safety of dual therapy (omitting acetylsalicylic acid)
compared to triple therapy in patients with atrial fibrillation and acute
coronary syndrome.
Study design
Multicentre open-label randomized controlled trial. The efficacy endpoint will
be analysed for non-inferiority whereas the safety endpoint will be analysed
for superiority.
Intervention
Random (1:1) allocation to dual therapy (OAC + 1 year P2Y12 inhibitor) versus
triple therapy (OAC + 1 year P2Y12 inhibitor + 1-12 moths ASA).
Study burden and risks
Currently there is no clear evidence for what antithrombotic therapy patients
with ACS and A-fib should receive. In daily practise prescribing dual or triple
therapy differs from hospital to hospital and from clinician to clinician.
Patients with a high risk of bleeding randomised to triple therapy or patients
with high thrombotic therapy randomised to dual therapy might have higher risk
of complications. However, it is not clear how we should identify this group so
they are not excluded from this study population. Since clinicians may be
worried about safety or efficacy in patients with a seemingly unfavourable risk
profile for the treatment assigned, as stated in section 8.6 the clinician may
add or stop antithrombotic agents without consequences for the study follow-up.
Koekoekslaan 1
Nieuwegein 3435CM
NL
Koekoekslaan 1
Nieuwegein 3435CM
NL
Listed location countries
Age
Inclusion criteria
Over 18 years of age
Acute coronary syndrome with elevated cardiac enzymes
Atrial fibrillation with long-term indication for oral anticoagulation
Exclusion criteria
Severe bleeding in past 3 months
Known coagulopathy
Contra-indications for intended medication (NOAC, P2Y12-remmer, ASA)
eGFR < 15 min/kg/1.73m2
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 |
|---|---|
| EudraCT | EUCTR2019-004805-28-NL |
| CCMO | NL71116.100.20 |