NCT02334254

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
420

participants targeted

Target at P75+ for phase_4 atrial-fibrillation

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 8, 2015

Status Verified

January 1, 2015

Enrollment Period

2.4 years

First QC Date

January 6, 2015

Last Update Submit

January 7, 2015

Conditions

Atrial Fibrillation

Keywords

safetyrivaroxabanticagreltriple antithrombotic regimenundergoing PCI

Outcome Measures

Primary Outcomes (1)

  • Major or clinically relevant non-major bleeding

    Major bleeding was assessed by the International Society of Thrombosis and Hemostasis (ISTH) definition. It included bleeding that was fatal, occurred in a critical location (intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, intramuscular with compartment syndrome, or pericardial), or was associated with a fall in hemoglobin of 2 g/dL or a transfusion of 2 units of packed red blood cells. Clinically relevant non-major bleeding was defined as bleeding that required medical or surgical intervention.

    12 months

Secondary Outcomes (1)

  • Composite outcome of death, myocardial infarction, stent thrombosis and ischemic stroke

    12 months

Study Arms (2)

Dual antithrombotic therapy (DAT)

EXPERIMENTAL

Dual Antithrombotic Therapy (DAT) regimen of rivaroxaban 2.5mg/5mg b.i.d. plus ticagrelor 90mg b.i.d.

Drug: rivaroxaban and ticagrel therapy

Triple antithrombotic therapy (TAT)

ACTIVE COMPARATOR

Triple antithrombotic therapy (TAT) regimen of aspirin 100mg q.d., clopidogrel 75mg q.d. plus warfarin (INR 1.8-2.5).

Drug: triple antithrombotic regimen with warfarin, asipirin and clopidogrel

Interventions

rivaroxaban and ticagrel therapyDRUG

Antiplatelet therapy are mandatory at least 1 month after bare metal stent implantation, and 6 months after drug-eluting stent implantation.

Dual antithrombotic therapy (DAT)
triple antithrombotic regimen with warfarin, asipirin and clopidogrelDRUG
Triple antithrombotic therapy (TAT)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital,Capital Medical University

Beijing, Beijing Municipality, 100029, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 26003433DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

RivaroxabanWarfarinClopidogrel

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingTiclopidineThienopyridinesPyridines

Study Officials

  • Yujie Zhou, MD

    Beijing Anzhen Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yujie Zhou, MD

CONTACT

86 18610323937yjzhou.az@gmail.com

Fei Gao, MD

CONTACT

1-347-257-4916fgaomd@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President of Beijing Anzhen Hospital, Capital Medical University

Study Record Dates

First Submitted

January 6, 2015

First Posted

January 8, 2015

Study Start

August 1, 2013

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 8, 2015

Record last verified: 2015-01

Locations

CN(1)