Trial Condition(s):
Prevention of atherothrombotic events, Coronary Artery Disease (CAD), Symptomatic peripheral artery disease (Symptomatic PAD)
Study to learn more about the safety and effectiveness of Rivaroxaban (Xarelto) when given together with Acetylsalicylic Acid to Indian people with narrowing of the arteries of the heart (CAD) and/or with reduced blood flow in the arteries of the legs and arms with symptoms (symptomatic PAD)
Bayer Identifier:
21269
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
This is an observational study in which data from Indian people with coronary artery disease and / or symptomatic peripheral artery disease who will be receiving the drug rivaroxaban (Xarelto) are studied.
Coronary artery disease (CAD) is a condition where the arteries that bring blood and oxygen to the heart become hardened and narrow. Peripheral artery disease (PAD) is a condition with reduced blood flow in the arteries of the legs and arms. People with CAD and / or PAD with symptoms may receive rivaroxaban from their doctors to prevent problems (for example, stoke) caused by blood clots and hardening of the arteries.
In this study researcher want to gather more information on the safety and the effectiveness of rivaroxaban when given together with the drug acetylsalicylic acid (also known as “aspirin”) to people with CAD and / or PAD with symptoms in the routine practice in India. Researchers are especially interested whether patients under treatment experience any events such as minor or major bleedings, stroke, sickness of the heart or blood vessels. In addition, information on why and when treating doctors decide to start or stop the treatment with rivaroxaban and acetylsalicylic acid is of interest to the researchers.
The study plans to enroll about 300 male or female patients who are at least 18 years old and are already treated with the two drugs or at least with rivaroxaban.
Inclusion Criteria
- Adult (≥18 years) patient. - Diagnosis of CAD or PAD. - Treatment with Rivaroxaban 2.5mg tablet, co administered with acetylsalicylic acid (ASA), for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events within 4 weeks prior to enrolment. also patients already on rivaroxaban treatment for ACS, who are subsequently fulfilling criteria for CAD, are allowed to be enrolled within 4 weeks of this decision being made. - Patients who are willing to participate in this study (signed informed consent).
Exclusion Criteria
- Contra-indications according to the local marketing authorization. - Patients who will be treated with chronic anticoagulation therapy other than rivaroxaban 2.5mg given for CAD/PAD. - Participation in an interventional trial.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Many locations Many locations, India | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
A phase IV study to investigate the safety and effectiveness of Rivaroxaban(Xarelto) 2.5mg [BID]+Acetylsalicylic Acid(ASA) 75mg [OD] in Indian patients with coronary and/or symptomatic peripheral artery disease
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Number of participants with haemorrhagic events and complicationsConsisting of minor and major bleeding events. The major bleeding complications are collected according to the International Society on Thrombosis and Haemostasis (ISTH) criteria as a composite of fatal bleeding, symptomatic bleeding into a critical organ (such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome), bleeding into surgical site requiring reoperation, bleeding leading to hospitalization.Timeframe: Up to 13 months
Secondary Outcome
- Number of participants with major adverse cardiovascular events (MACE)MACE: composite of MI, stroke, and cardiovascular death (and single components)Timeframe: Up to 13 months
- Number of participants with major adverse limb events (MALE)MALE: Major adverse limb events, incl. major amputation (and single components), and antithrombotic treatment patterns after MALETimeframe: Up to 13 months
- Number of participants with thromboembolic eventsThromboembolic events includes systemic embolism, venous thromboembolismTimeframe: Up to 13 months
- Number of participants with cardiovascular mortalityTimeframe: Up to 13 months
- Number of participants with all-cause mortalityTimeframe: Up to 13 months
- Number of participants with cardiac revascularization proceduresCardiac revascularization procedure includes Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafting (CABG)Timeframe: Up to 13 months
- Number of participants with peripheral revascularization proceduresTimeframe: Up to 13 months
- Number of participants with carotid revascularization proceduresTimeframe: Up to 13 months
- Duration of hospitalizationsHospitalizations includes stroke, cardiovascular reasons, MALE, or bleeding complications.Timeframe: Up to 13 months
- Total and pain free walking distance per individual for PAD patientsTimeframe: Change from baseline up to 13 months
- Number of participants with history and diagnosis of CAD or PADHistory and diagnosis of CAD, incl. history of myocardial infarction and vessel status. History and diagnosis of PAD, incl. ankle-brachial index (ABI).Timeframe: Up to 13 months
- Number of participants with individual riskIndividual Risk classification: Co-morbidities (e.g. worsening symptoms, diabetes mellitus, chronic heart failure (CHF) renal impairment (eGFR <60 ml/min), Cerebrovascular disease(, ≥ 2 peripheral vascular beds affected, intermittent claudication, ABI <0.9, smoking, hypertension, hyperlipidaemia, carotid stenosis), and routinely collected key laboratory data.Timeframe: Up to 13 months
- Number of participants with revascularization procedures and prior interventions (PCI, CABG), peripheral revascularization proceduresTimeframe: Up to 13 months
- Type of prior and concomitant antithrombotic treatment and other secondary prevention therapies in patients with CAD or PADTimeframe: Up to 13 months
- Dose of prior and concomitant antithrombotic treatment and other secondary prevention therapies in patients with CAD or PADTimeframe: Up to 13 months
- Duration of prior and concomitant antithrombotic treatment and other secondary prevention therapies in patients with CAD or PADTimeframe: Up to 13 months
- Reasons and decision points for introducing rivaroxaban 2.5 mg [BID]BID: twice per day dosingTimeframe: Up to 13 months
- Reasons for discontinuation of rivaroxaban 2.5 mg [BID].Timeframe: Up to 13 months
- Planned and actual duration of treatment with rivaroxaban 2.5 mg [BID].Timeframe: Up to 13 months
- Planned and actual duration of treatment with ASA 75 mg [OD]QD:once per day dosingTimeframe: Up to 13 months
Additional Information
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