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Completed

NCT Number: NCT04298567

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)

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.

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Key information

Conditions

Prevention of Atherothrombotic Events Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Artery Disease (CAD) Coronary Disease Heart Diseases Myocardial Ischemia Symptomatic Peripheral Artery Disease (Symptomatic PAD) Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many locations

Multiple Locations, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rivaroxaban (Xarelto,Bay 59-7939)

Drug

Rivaroxaban (2.5 mg [BID])

Acetylsalicylic acid(ASA)

Drug

ASA (75mg [QD]; dose according to local label.

Primary outcomes

  1. Number of participants with haemorrhagic events and complications

    Time frame: Up to 13 months

    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.

Secondary outcomes

  1. Number of participants with major adverse cardiovascular events (MACE)

    Time frame: Up to 13 months

    MACE: composite of MI, stroke, and cardiovascular death (and single components)

  2. Number of participants with major adverse limb events (MALE)

    Time frame: Up to 13 months

    MALE: Major adverse limb events, incl. major amputation (and single components), and antithrombotic treatment patterns after MALE

  3. Number of participants with thromboembolic events

    Time frame: Up to 13 months

    Thromboembolic events includes systemic embolism, venous thromboembolism

  4. Number of participants with cardiovascular mortality

    Time frame: Up to 13 months

  5. Number of participants with all-cause mortality

    Time frame: Up to 13 months

  6. Number of participants with cardiac revascularization procedures

    Time frame: Up to 13 months

    Cardiac revascularization procedure includes Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafting (CABG)

  7. Number of participants with peripheral revascularization procedures

    Time frame: Up to 13 months

  8. Number of participants with carotid revascularization procedures

    Time frame: Up to 13 months

  9. Duration of hospitalizations

    Time frame: Up to 13 months

    Hospitalizations includes stroke, cardiovascular reasons, MALE, or bleeding complications.

  10. Total and pain free walking distance per individual for PAD patients

    Time frame: Change from baseline up to 13 months

  11. Number of participants with history and diagnosis of CAD or PAD

    Time frame: Up to 13 months

    History and diagnosis of CAD, incl. history of myocardial infarction and vessel status.

    History and diagnosis of PAD, incl. ankle-brachial index (ABI).

  12. Number of participants with individual risk

    Time frame: Up to 13 months

    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.

  13. Number of participants with revascularization procedures and prior interventions (PCI, CABG), peripheral revascularization procedures

    Time frame: Up to 13 months

  14. Type of prior and concomitant antithrombotic treatment and other secondary prevention therapies in patients with CAD or PAD

    Time frame: Up to 13 months

  15. Dose of prior and concomitant antithrombotic treatment and other secondary prevention therapies in patients with CAD or PAD

    Time frame: Up to 13 months

  16. Duration of prior and concomitant antithrombotic treatment and other secondary prevention therapies in patients with CAD or PAD

    Time frame: Up to 13 months

  17. Reasons and decision points for introducing rivaroxaban 2.5 mg [BID]

    Time frame: Up to 13 months

    BID: twice per day dosing

  18. Reasons for discontinuation of rivaroxaban 2.5 mg [BID].

    Time frame: Up to 13 months

  19. Planned and actual duration of treatment with rivaroxaban 2.5 mg [BID].

    Time frame: Up to 13 months

  20. Planned and actual duration of treatment with ASA 75 mg [OD]

    Time frame: Up to 13 months

    QD:once per day dosing

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 6, 2020
Registry last updated
Jun 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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