NCT02789917: APPROACH

APixaban Versus PhenpRocoumon: Oral AntiCoagulation Plus Antiplatelet tHerapy in Patients With Acute Coronary Syndrome and Atrial Fibrillation

Completed Phase 4 Last updated 12 August 2020

What this trial tests

Phase 4 trial testing Dual Therapy in Acute Coronary Syndrome in 403 participants. Completed in 1 August 2020.

Timeline

1 June 2016

Primary endpoint
1 August 2020

1 August 2020

Quick facts

Lead sponsor	LMU Klinikum
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	403
Start date	1 June 2016
Primary completion	1 August 2020
Estimated completion	1 August 2020
Sites	16 locations across Germany

Drugs / interventions tested

• Dual Therapy — full drug profile →
• Triple Therapy

Conditions studied

• Acute Coronary Syndrome — all drugs for Acute Coronary Syndrome →
• Atrial Fibrillation — all drugs for Atrial Fibrillation →
• Coronary Artery Disease — all drugs for Coronary Artery Disease →

Sponsor

LMU Klinikum — full company profile →

Who can join

18 and older, any sex, with Acute Coronary Syndrome or Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The combined endpoint of moderate or major bleeding complications during the initial hospitalization and follow up (Bleeding Academic Research Consortium (BARC) type ≥ 2 bleeding)
  Time frame: up to 6 months after randomization

Sponsor's own description

It is hypothesised that a dual therapy strategy by oral anticoagulation with the new Factor-Xa-inhibitor apixaban plus clopidogrel is superior to a triple therapy regimen with phenprocoumon plus acetylsalicylic acid (ASA) and clopidogrel with respect to avoiding bleeding events in patients with atrial fibrillation undergoing percutaneous coronary intervention in the setting of an acute coronary syndrome.

Publications & conference data

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

1. Dual Versus Triple Therapy for Atrial Fibrillation After Percutaneous Coronary Intervention: A Systematic Review and Meta-analysis.
   Khan SU, Osman M, Khan MU, Khan MS, et al · · 2020 · cited 28× · PMID 32176890 · DOI 10.7326/m19-3763
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. Non-vitamin K antagonist oral anticoagulants (NOACs) post-percutaneous coronary intervention: a network meta-analysis.
   Al Said S, Alabed S, Kaier K, Tan AR, et al · · 2019 · cited 8× · PMID 31858590 · DOI 10.1002/14651858.cd013252.pub2
4. Double Jeopardy: Will the new trials tell us how to manage patients with atrial fibrillation and coronary artery disease?
   Wakili R, Riesinger L, Fender AC, Dobrev D. · · 2019 · cited 5× · PMID 31111088 · DOI 10.1016/j.ijcha.2019.100369
5. Apixaban versus PhenpRocoumon: Oral AntiCoagulation plus antiplatelet tHerapy in patients with Acute Coronary Syndrome and Atrial Fibrillation (APPROACH-ACS-AF): Rationale and design of the prospective randomized parallel-group, open-label, blinded-endpoint, superiority, multicen
   Riesinger L, Strobl C, Leistner DM, Gori T, et al · · 2021 · cited 4× · PMID 34258380 · DOI 10.1016/j.ijcha.2021.100810
6. Recent highlights on specific aspects of oral anticoagulation in difficult clinical scenarios from the <i>International Journal of Cardiology Heart & Vasculature</i>.
   Fender AC, Dobrev D. · · 2023 · cited 2× · PMID 37663615 · DOI 10.1016/j.ijcha.2023.101260