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)

NCT04298567 | Completed

• 1 other identifier: 21269
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prevention of Atherothrombotic Events; Coronary Artery Disease (CAD); Symptomatic Peripheral Artery Disease (Symptomatic PAD)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Number of participants with major adverse cardiovascular events (MACE)

  Up to 13 months

• Number of participants with major adverse limb events (MALE)

  Up to 13 months

• Number of participants with thromboembolic events

  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

Study Arms (1)

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); Drug: Acetylsalicylic acid(ASA)

Interventions

Rivaroxaban (Xarelto,Bay 59-7939) DRUG

Rivaroxaban (2.5 mg \[BID\])

Treatment

Acetylsalicylic acid(ASA) DRUG

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

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many locations

Multiple Locations, India

Location

Related 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.

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Rivaroxaban; Aspirin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: March 6, 2020
• Study Start: February 25, 2022
• Primary Completion: March 28, 2024
• Study Completion: June 6, 2024
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)