Clinical trial NCT02334254: Rivaroxaban in Patients With Atrial Fibrillation and Coronary Artery Disease Undergoing Percutaneous Coronary Intervention
Official title: Rivaroxaban in Patients With Atrial Fibrillation and Coronary Artery Disease Undergoing Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atrial Fibrillation
Keywords: safety
rivaroxaban
ticagrel
triple antithrombotic regimen
undergoing PCI
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2015-01-08
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety for the combination of Rivaroxaban and Ticagrel versus triple antithrombotic regimen (Vitamin K Antagonist (VKA), Clopigogrel and Aspirin) in patients with atrial fibrillation and coronary artery disease undergoing percutaneous coronary intervention (PCI).

Detailed description: This is an open-label (both physician and participant know the treatment that the participant receives), randomized (study medication is assigned by chance), multicenter clinical study assessing the safety of the combination of rivaroxaban and ticagrel versus triple antithrombotic regimen (warfarin, clopigogrel and aspirin) in patients, who have paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF) and concomitant coronary artery disease undergoing percutaneous coronary intervention (PCI). A target of 420 participants will be randomized into the study, with approximately 210 participants in each treatment strategy group. Primary comparisons will be made of the rates of major and clinically relevant bleeding, assessed by the modified International Society of Thrombosis and Haemostasis (ISTH) classification. The study consists of a screening phase, a 12-month open-label treatment phase, and an end-of-treatment/early withdrawal visit. The total duration of participation in the study for each participant is approximately 12 months.

Eligibility criteria: Inclusion Criteria:

* a long-term indication for oral anticoagulation treatment (until at least 1 year after the study)
* a severe coronary lesion (at least 75% stenosis on angiography or fractional flow reserve lower than 0•80) with indication for PCI
* age 18-80 years

Exclusion Criteria:

* history of intracranial bleeding;
* cardiogenic shock;
* contra indication to use of antiplatelet or anticoagulation drugs;
* peptic ulcer in the previous 6 months;
* thrombo cytopenia (platelet concentration lower than 50\~10⁹/L);
* major bleeding (according to the Thrombolysis in Myocardial Infarction \[TIMI\] criteria) in the past 12 months; and
* pregnancy.

Primary outcomes:
measure: Major or clinically relevant non-major bleeding
timeFrame: 12 months
Secondary outcomes:
measure: Composite outcome of death, myocardial infarction, stent thrombosis and ischemic stroke
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital,Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Anzhen Hospital
name: Yujie Zhou, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gao F, Shen H, Wang ZJ, Yang SW, Liu XL, Zhou YJ. Rationale and design of the RT-AF study: Combination of rivaroxaban and ticagrelor in patients with atrial fibrillation and coronary artery disease undergoing percutaneous coronary intervention. Contemp Clin Trials. 2015 Jul;43:129-32. doi: 10.1016/j.cct.2015.05.012. Epub 2015 May 21.