CompletedNot Applicable

Study to Gain Insights in Treatment Patterns and Outcomes in Patients With Atherosclerosis Prescribed to Xarelto in Combination With Acetylsalicylic Acid

Argentina, Brazil, Canada5,798 participantsStarted 2018-11-13

Plain-language summary

In this study researchers want to gain more information on treatment patterns of patients treated with Xarelto in combination with acetylsalicylic acid (ASA). Both drugs reduce the risk of blood clots via different pathways. The study will enroll adult patients suffering from coronary artery disease (narrowing or blockage of vessels that supply the heart with blood) or peripheral artery disease (narrowing or blockage of vessels that supply the legs or head with blood). The study will focus on information on when and why physicians are starting to treat patients with Xarelto in addition to ASA, treatment duration, reasons to discontinue treatment and previous therapies. The study will also look into treatment outcomes for patients being treated with a combination of Xarelto and ASA by their physicians.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults with diagnosis Coronary Artery Disease (CAD) or Peripheral Artery Disease (PAD). * Treatment according to local marketing authorization, rivaroxaban 2.5 mg twice daily started within 4 weeks prior to enrolment. Only in those countries with a marketing authorization of rivaroxaban in the acute coronary syndrome (ACS) indication, 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. Exclusion Criteria: * Patients who will be treated with chronic anticoagulation therapy other than rivaroxaban 2.5 mg given for CAD/PAD. * Participation in an interventional trial.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Descriptive analysis of patient history of CAD

Timeframe: At baseline

Descriptive analysis of patient history of PAD

Timeframe: At baseline

Descriptive analysis of prior antithrombotic treatment

Timeframe: At baseline

Descriptive analysis of concomitant antithrombotic treatment

Timeframe: Up to 30.5 months

Descriptive analysis of prior secondary prevention therapies

Timeframe: At baseline

Descriptive analysis of concomitant secondary prevention therapies

Timeframe: Up to 30.5 months

Reason for start of rivaroxaban

Timeframe: At baseline

Trial details

NCT IDNCT03746275

SponsorBayer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-06-08

View on ClinicalTrials.gov More Atherosclerosis trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Descriptive analysis of patient history of CAD

Timeframe: At baseline

Descriptive analysis of patient history of PAD

Timeframe: At baseline

Descriptive analysis of prior antithrombotic treatment

Timeframe: At baseline

Descriptive analysis of concomitant antithrombotic treatment

Timeframe: Up to 30.5 months

Descriptive analysis of prior secondary prevention therapies

Timeframe: At baseline

Descriptive analysis of concomitant secondary prevention therapies

Timeframe: Up to 30.5 months

Reason for start of rivaroxaban

Timeframe: At baseline