Monotherapy With P2Y12 Inhibitors in Patients With Atrial fIbrillation Undergoing Supraflex Stent Implantation

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorInsel Gruppe AG, University Hospital Bern

About this trial

Patients with atrial fibrillation undergoing percutaneous coronary intervention with stent implantation require treatment with different antithrombotic drugs. Oral anticoagulants are prescribed to reduce the risk of stroke associated with atrial fibrillation. Antiplatelet substances are prescribed after stent implantation to reduce the risk of adverse cardiac events such as myocardial infarction or stent thrombosis. Treatment with antithrombotic medications can cause bleeding complications, particularly when these substances are combined.

The currently recommended standard strategy consists of treatment with 3 antithrombotic medications for at least 1 week up to one month, followed by treatment with two of these medications for up to 6-12 months after stent implantation. Thereafter, patients usually receive long-term treatment with only one drug, an anticoagulant.

In the monotherapy group of this study, the investigators will investigate a strategy where only one antithrombotic drug will be used at a time. During the first month after stent implantation, the investigators will prescribe an antiplatelet medication, followed by an oral anticoagulant as monotherapy. This strategy might be associated with fewer bleeding complications, while protecting adequately against thrombotic events.

In this study the investigators would like to investigate whether treatment with a single antithrombotic drug ("monotherapy strategy") is associated with benefits compared to the currently recommended combination therapy of antithrombotic medications ("standard-of-care strategy").

Eligibility criteria

Qualifiers

Age ≥18 years

Atrial fibrillation or flutter with an indication for oral anticoagulation using direct-acting oral anticoagulants (DOACs) for ≥12 months

Successful percutaneous coronary intervention in at least 1 lesion within the previous 7 days with no remaining lesions intended for treatment.

Free from major adverse events post qualifying PCI, including new onset chest pain suspected to be of ischemic origin, acute or subacute stent thrombosis, new-onset neurological signs or symptoms.

Disqualifiers

Planned staged percutaneous intervention procedure (Patients can be enrolled after complete coronary revascularization with no remaining lesions intended for treatment. Patients who have or develop indication to percutaneous valve intervention can undergo treatment more than 30 days after qualifying PCI.)

Cardioversion for treatment of atrial fibrillation within 1 month prior to inclusion or planned cardioversion

AF ablation procedure within 2 months prior to inclusion or planned AF ablation procedure

Prior mechanical valvular prosthesis implantation

Trial design

Treatments tested in this trial

  • P2Y12 inhibitor
  • Aspirin
  • DOAC

Treatment groups

3,010 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Insel Gruppe AG, University Hospital Bern

Lead sponsor

Sahajanand Medical Technologies Limited

Collaborator