Trial Condition(s):

Coronary artery disease, Peripheral Artery Disease

A study to collect data on the treatment pattern of Xarelto + Acetylsalicylic Acid in the routine clinical practice in patients who are suffering from a condition that narrows the blood vessels supplying the heart and / or a condition that most commonly narrows the blood vessel in the legs (XATOC)

Bayer Identifier:

21283

ClinicalTrials.gov Identifier:

NCT04401761

EudraCT Number:

Not Available

Recruiting

Trial Purpose

The study will focus on effectiveness and safety of rivaroxaban (Xarelto) when given together with acetylsalicylic acid (combination therapy) to patients suffering from coronary artery disease (a condition that affects the blood vessels supplying the heart) and / or peripheral artery disease (a condition that affects the blood vessels of the lower limbs) in the routine clinical practice. The study will help to collect data for prevention cardiovascular death, myocardial infarction (MI), stroke and major adverse limb events in adult patients. The study will focus on information on when and why physicians are starting to treat patients with combination therapy, treatment duration, reasons to discontinue treatment and previous therapies. The study will also investigate treatment outcomes for patients being treated with a combination therapy by their physicians.

Inclusion Criteria
- Adult (≥18 years) patient (except Taiwan ≥ 20 years old).
- Diagnosis of CAD or symptomatic PAD.
- Treatment according to local marketing authorization, rivaroxaban 2.5 mg [BID] plus Acetylsalicylic acid (ASA) 75-100 mg [OD] started up to 4 weeks before or after the ICF is signed.
- Only in those countries with a marketing authorization of rivaroxaban in the Acute Coronary Syndrome (ACS) indication, patients already on rivaroxaban treatment for ACS for more than 4 weeks, who are subsequently fulfilling criteria for CAD, are also allowed to be enrolled.
Exclusion Criteria
- Contra-indications according to the local marketing authorization.
- Patients who will be treated with chronic anticoagulation therapy other than rivaroxaban 2.5 mg given for CAD/PAD.
- Participation in an interventional trial.
- Enrolment in the XATOA study.

Trial Summary

Enrollment Goal
3070
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)+ASA
Accepts Healthy Volunteers
N/A

Where to Participate

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Locations
Status
LocationsStatus
Locations

Many Locations

Many Locations, Belgium

Status
Recruiting
 
Locations

Many Locations

Many Locations, Switzerland

Status
Active, not recruiting
 
Locations

Many Locations

Many Locations, China

Status
Recruiting
 
Locations

Many Locations

Many Locations, Colombia

Status
Recruiting
 
Locations

Many Locations

Many Locations, Spain

Status
Recruiting
 
Locations

Many Locations

Many Locations, Italy

Status
Recruiting
 
Locations

Many Locations

Many Locations, South Korea

Status
Recruiting
 
Locations

Many Locations

Many Locations, Russia

Status
Active, not recruiting
 
Locations

Many Locations

Many Locations, Slovenia

Status
Active, not recruiting
 
Locations

Many Locations

Many Locations, Taiwan, China

Status
Recruiting
 
Locations

Many Locations

Many Locations, Brazil

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Canada

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, United Kingdom

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Saudi Arabia

Status
Not yet recruiting
 

Trial Design