NCT04217447: AQUATIC

Assessment of Quitting Versus Using Aspirin Therapy In Patients Treated With Oral Anticoagulation for Atrial Fibrillation or Other Indication With Stabilized Coronary Artery Disease

Terminated Phase 3 Last updated 10 July 2025

What this trial tests

Phase 3 trial testing OAC + Aspirin 100mg od in Coronary Artery Disease in 874 participants. Terminated before completion.

Timeline

25 May 2020

Primary endpoint
28 October 2024

28 October 2024

Quick facts

Lead sponsor	University Hospital, Brest
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	874
Start date	25 May 2020
Primary completion	28 October 2024
Estimated completion	28 October 2024
Sites	51 locations across France

Drugs / interventions tested

• OAC + Aspirin 100mg od — full drug profile →
• OAC + placebo of Aspirin 100mg od — full drug profile →

Conditions studied

• Coronary Artery Disease — all drugs for Coronary Artery Disease →

Sponsor

University Hospital, Brest

Who can join

18 and older, any sex, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

* Long-term aspirin (ASA) is the standard recommended antithrombotic therapy in patients with stable coronary artery disease (CAD), especially following stenting (Class I, Level A).
* Long-term oral anticoagulation (OAC) is the standard antithrombotic therapy in patients with atrial fibrillation (AF) associated with one or more risk factor for stroke (Class I, Level A).
* During the first year following acute coronary syndrome (ACS) and/or percutaneous coronary intervention (PCI), several studies evaluating the combination of OAC treatment and antiplatelet therapy are either already published or ongoing.
* At distance of the index ACS and/or PCI, patients with stable CAD and concomitant AF remain at particular high-risk of ischemic (3 to 4 times higher as compared to patients with stable CAD without AF) and bleeding events. Antithrombotic management of these patients is subsequently highly challenging in clinical practice. The European task force suggests that the use of a full-dose anticoagulant monotherapy without any antiplatelet therapy should be the default strategy in such patients with both, AF and stable CAD.
* However, evidences are sparse and weak to support such a strategy (only observational studies with many biases) and no randomized trial has assessed this question. These patients, especially those at high-risk of recurrent ischemic events (post- ACS, diabetes, multivessel CAD…) may benefit from the combination of OAC and aspirin at long-term. Indeed the crude event rate of ischemic events is much higher than the crude event rate of bleeding in this specific population. Ischemic events are 2 to 3 times more frequent than bleeding in daily practice.
* The benefit/risk ratio of these two different strategies (ASA in combination with OAC vs. OAC alone) in patients at high-risk of recurrent coronary and vascular events remains unknown. Dual therapy with full-dose anticoagulation and ASA may lead to higher risk of major bleeding, while stopping ASA in stabilized high-risk patients after PCI may lead to poorer outcome regarding ischemic events.
* The coordinating investigators therefore designed a double blind placebo controlled trial in order to assess the optimal antithrombotic regimen that should be pursued long-life in this subset of patients.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Aspirin in Patients with Chronic Coronary Syndrome Receiving Oral Anticoagulation.
   Lemesle G, Didier R, Steg PG, Simon T, et al · · 2025 · cited 18× · PMID 40888725 · DOI 10.1056/nejmoa2507532
2. Antithrombotic Management in AF Patients Following Percutaneous Coronary Intervention: A European Perspective.
   Greco A, Laudani C, Rochira C, Capodanno D. · · 2023 · cited 12× · PMID 37601736 · DOI 10.15420/icr.2021.30
3. Trends in Off-Label Indications of Non-Vitamin K Antagonist Oral Anticoagulants in Acute Coronary Syndrome.
   Kaddoura R, Orabi B, Yassin MA, Omar AS. · · 2023 · cited 1× · PMID 39077529 · DOI 10.31083/j.rcm2406180