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)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease (CAD); Prevention of Atherothrombotic Events; Symptomatic Peripheral Artery Disease (Symptomatic PAD)
• Intervention / Treatment: Drug: Rivaroxaban (Xarelto,Bay 59-7939); Drug: Acetylsalicylic acid(ASA)

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• India
  • Multiple Locations, India
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Female and male patients with a diagnosis of CAD or symptomatic PAD will be enrolled within 4 weeks after the decision for treatment with rivaroxaban plus ASA has been made by the investigator.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment; Female and male patients with a diagnosis of CAD or symptomatic PAD will be enrolled within 4 weeks after the decision for treatment with rivaroxaban 2.5mg [BID] plus ASA 75mg [OD] has been made by the investigator.	Drug: Rivaroxaban (Xarelto,Bay 59-7939); Rivaroxaban (2.5 mg [BID]); Drug: Acetylsalicylic acid(ASA); ASA (75mg [QD]; dose according to local label.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 13 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with major adverse cardiovascular events (MACE)	MACE: composite of MI, stroke, and cardiovascular death (and single components)	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	Up to 13 months
Number of participants with thromboembolic events	Thromboembolic events includes systemic embolism, venous thromboembolism	Up to 13 months
Number of participants with cardiovascular mortality		Up to 13 months
Number of participants with all-cause mortality		Up to 13 months
Number of participants with cardiac revascularization procedures	Cardiac revascularization procedure includes Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafting (CABG)	Up to 13 months
Number of participants with peripheral revascularization procedures		Up to 13 months
Number of participants with carotid revascularization procedures		Up to 13 months
Duration of hospitalizations	Hospitalizations includes stroke, cardiovascular reasons, MALE, or bleeding complications.	Up to 13 months
Total and pain free walking distance per individual for PAD patients		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).	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.	Up to 13 months
Number of participants with revascularization procedures and prior interventions (PCI, CABG), peripheral revascularization procedures		Up to 13 months
Type of prior and concomitant antithrombotic treatment and other secondary prevention therapies in patients with CAD or PAD		Up to 13 months
Dose of prior and concomitant antithrombotic treatment and other secondary prevention therapies in patients with CAD or PAD		Up to 13 months
Duration of prior and concomitant antithrombotic treatment and other secondary prevention therapies in patients with CAD or PAD		Up to 13 months
Reasons and decision points for introducing rivaroxaban 2.5 mg [BID]	BID: twice per day dosing	Up to 13 months
Reasons for discontinuation of rivaroxaban 2.5 mg [BID].		Up to 13 months
Planned and actual duration of treatment with rivaroxaban 2.5 mg [BID].		Up to 13 months
Planned and actual duration of treatment with ASA 75 mg [OD]	QD:once per day dosing	Up to 13 months

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2022
• Primary Completion (Actual): March 28, 2024
• Study Completion (Estimated): May 14, 2024

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: March 5, 2020
• First Posted (Actual): March 6, 2020

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Coronary Disease; Peripheral Vascular Diseases; Coronary Artery Disease; Peripheral Arterial Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Aspirin; Rivaroxaban
• Other Study ID Numbers: 21269

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No