check_circleStudy Completed

Prevention of atherothrombotic events, Coronary artery disease (CAD), Symptomatic peripheral artery disease (Symptomatic PAD)

Bayer Identifier:

21269

ClinicalTrials.gov Identifier:

NCT04298567

EudraCT Number:

Not Available

EU CT Number:

Not Available
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)

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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).
  • - 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
300
Trial Dates
February 2022 - June 2024
Phase
Phase 4
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)+ASA
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
Many locationsMany locations, India

Primary Outcome

  • Number of participants with haemorrhagic events and complications
    Consisting 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.
    date_rangeTime Frame:
    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)
    date_rangeTime Frame:
    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 MALE
    date_rangeTime Frame:
    Up to 13 months
  • Number of participants with thromboembolic events
    Thromboembolic events includes systemic embolism, venous thromboembolism
    date_rangeTime Frame:
    Up to 13 months
  • Number of participants with cardiovascular mortality
    date_rangeTime Frame:
    Up to 13 months
  • Number of participants with all-cause mortality
    date_rangeTime Frame:
    Up to 13 months
  • Number of participants with cardiac revascularization procedures
    Cardiac revascularization procedure includes Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafting (CABG)
    date_rangeTime Frame:
    Up to 13 months
  • Number of participants with peripheral revascularization procedures
    date_rangeTime Frame:
    Up to 13 months
  • Number of participants with carotid revascularization procedures
    date_rangeTime Frame:
    Up to 13 months
  • Duration of hospitalizations
    Hospitalizations includes stroke, cardiovascular reasons, MALE, or bleeding complications.
    date_rangeTime Frame:
    Up to 13 months
  • Total and pain free walking distance per individual for PAD patients
    date_rangeTime Frame:
    Change from baseline up to 13 months
  • Number of participants with history and diagnosis of CAD or PAD
    History and diagnosis of CAD, incl. history of myocardial infarction and vessel status. History and diagnosis of PAD, incl. ankle-brachial index (ABI).
    date_rangeTime Frame:
    Up to 13 months
  • Number of participants with individual risk
    Individual 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.
    date_rangeTime Frame:
    Up to 13 months
  • Number of participants with revascularization procedures and prior interventions (PCI, CABG), peripheral revascularization procedures
    date_rangeTime Frame:
    Up to 13 months
  • Type of prior and concomitant antithrombotic treatment and other secondary prevention therapies in patients with CAD or PAD
    date_rangeTime Frame:
    Up to 13 months
  • Dose of prior and concomitant antithrombotic treatment and other secondary prevention therapies in patients with CAD or PAD
    date_rangeTime Frame:
    Up to 13 months
  • Duration of prior and concomitant antithrombotic treatment and other secondary prevention therapies in patients with CAD or PAD
    date_rangeTime Frame:
    Up to 13 months
  • Reasons and decision points for introducing rivaroxaban 2.5 mg [BID]
    BID: twice per day dosing
    date_rangeTime Frame:
    Up to 13 months
  • Reasons for discontinuation of rivaroxaban 2.5 mg [BID].
    date_rangeTime Frame:
    Up to 13 months
  • Planned and actual duration of treatment with rivaroxaban 2.5 mg [BID].
    date_rangeTime Frame:
    Up to 13 months
  • Planned and actual duration of treatment with ASA 75 mg [OD]
    QD:once per day dosing
    date_rangeTime Frame:
    Up to 13 months

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
N/A

Additional Information

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