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Trial record 96 of 156 for:    warfarin AND Vitamin K

Rivaroxaban in Patients With Atrial Fibrillation and Coronary Artery Disease Undergoing Percutaneous Coronary Intervention

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ClinicalTrials.gov Identifier: NCT02334254
Recruitment Status : Unknown
Verified January 2015 by Yujie Zhou, Beijing Anzhen Hospital.
Recruitment status was:  Recruiting
First Posted : January 8, 2015
Last Update Posted : January 8, 2015
Sponsor:
Information provided by (Responsible Party):
Yujie Zhou, Beijing Anzhen Hospital

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).

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: rivaroxaban and ticagrel therapy Drug: triple antithrombotic regimen with warfarin, asipirin and clopidogrel Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rivaroxaban in Patients With Atrial Fibrillation and Coronary Artery Disease Undergoing Percutaneous Coronary Intervention
Study Start Date : August 2013
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Arm Intervention/treatment
Experimental: Dual antithrombotic therapy (DAT)
Dual Antithrombotic Therapy (DAT) regimen of rivaroxaban 2.5mg/5mg b.i.d. plus ticagrelor 90mg b.i.d.
Drug: rivaroxaban and ticagrel therapy
Antiplatelet therapy are mandatory at least 1 month after bare metal stent implantation, and 6 months after drug-eluting stent implantation.

Active Comparator: Triple antithrombotic therapy (TAT)
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



Primary Outcome Measures :
  1. Major or clinically relevant non-major bleeding [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Composite outcome of death, myocardial infarction, stent thrombosis and ischemic stroke [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02334254


Contacts
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Contact: Yujie Zhou, MD 86 18610323937 yjzhou.az@gmail.com
Contact: Fei Gao, MD 1-347-257-4916 fgaomd@163.com

Locations
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China, Beijing
Beijing Anzhen Hospital,Capital Medical University Recruiting
Beijing, Beijing, China, 100029
Contact: Fei Gao, MD    1-347-257-4916    fgaomd@163.com   
Contact: Hua Shen, MD    86 13718667442    shenhua0402@163.com   
Sponsors and Collaborators
Beijing Anzhen Hospital
Investigators
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Principal Investigator: Yujie Zhou, MD Beijing Anzhen Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yujie Zhou, Vice President of Beijing Anzhen Hospital, Capital Medical University, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier: NCT02334254     History of Changes
Other Study ID Numbers: anzhen2013009
First Posted: January 8, 2015    Key Record Dates
Last Update Posted: January 8, 2015
Last Verified: January 2015
Keywords provided by Yujie Zhou, Beijing Anzhen Hospital:
safety
rivaroxaban
ticagrel
triple antithrombotic regimen
undergoing PCI
Additional relevant MeSH terms:
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Warfarin
Atrial Fibrillation
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Rivaroxaban
Clopidogrel
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors