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)

Coronary Artery Disease (CAD) Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04298567
• Other study ID #: 21269
• Status: Active, not recruiting
• Start date: February 25, 2022
• Est. completion date: June 5, 2024

Study information

• Verified date: May 2024
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: June 5, 2024
• Est. primary completion date: March 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease (CAD)
• Peripheral Arterial Disease

Intervention

Drug:
• Rivaroxaban (Xarelto,Bay 59-7939)
Rivaroxaban (2.5 mg [BID])
• Acetylsalicylic acid(ASA)
ASA (75mg [QD]; dose according to local label.

Locations

Country	Name	City	State
India	Many locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

India, 

Outcome

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

External Links

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