Prevention of Atherothrombotic EventsNCT04298567
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)
An observational study of Prevention of Atherothrombotic Events and Coronary Artery Disease (CAD), run by Bayer at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prevention of Atherothrombotic Events, Coronary Artery Disease (CAD), Symptomatic Peripheral Artery Disease (Symptomatic PAD)
- What is being tested?
- Rivaroxaban (Xarelto,Bay 59-7939) and Acetylsalicylic acid(ASA)
- How many people
- 300 participants
- Where
- 1 siteIndia
- Study dates
- 25 Feb 2022to 6 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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)
- Being tested
- Rivaroxaban (Xarelto,Bay 59-7939), Acetylsalicylic acid(ASA)
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban (Xarelto,Bay 59-7939)Drug
Rivaroxaban (2.5 mg [BID])
Acetylsalicylic acid(ASA)Drug
ASA (75mg [QD]; dose according to local label.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Rivaroxaban (Xarelto,Bay 59-7939); Drug: Acetylsalicylic acid(ASA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 13 months
Secondary outcomes (20)
Number of participants with major adverse cardiovascular events (MACE)
MACE: composite of MI, stroke, and cardiovascular death (and single components)
Measured: 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
Measured: Up to 13 months
Number of participants with thromboembolic events
Thromboembolic events includes systemic embolism, venous thromboembolism
Measured: Up to 13 months
Number of participants with cardiovascular mortality
Measured: Up to 13 months
Number of participants with all-cause mortality
Measured: Up to 13 months
Number of participants with cardiac revascularization procedures
Cardiac revascularization procedure includes Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafting (CABG)
Measured: Up to 13 months
Number of participants with peripheral revascularization procedures
Measured: Up to 13 months
Number of participants with carotid revascularization procedures
Measured: Up to 13 months
Duration of hospitalizations
Hospitalizations includes stroke, cardiovascular reasons, MALE, or bleeding complications.
Measured: Up to 13 months
Total and pain free walking distance per individual for PAD patients
Measured: 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).
Measured: 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.
Measured: Up to 13 months
Number of participants with revascularization procedures and prior interventions (PCI, CABG), peripheral revascularization procedures
Measured: Up to 13 months
Type of prior and concomitant antithrombotic treatment and other secondary prevention therapies in patients with CAD or PAD
Measured: Up to 13 months
Dose of prior and concomitant antithrombotic treatment and other secondary prevention therapies in patients with CAD or PAD
Measured: Up to 13 months
Duration of prior and concomitant antithrombotic treatment and other secondary prevention therapies in patients with CAD or PAD
Measured: Up to 13 months
Reasons and decision points for introducing rivaroxaban 2.5 mg [BID]
BID: twice per day dosing
Measured: Up to 13 months
Reasons for discontinuation of rivaroxaban 2.5 mg [BID].
Measured: Up to 13 months
Planned and actual duration of treatment with rivaroxaban 2.5 mg [BID].
Measured: Up to 13 months
Planned and actual duration of treatment with ASA 75 mg [OD]
QD:once per day dosing
Measured: Up to 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start25 Feb 2022
- Primary completion28 Mar 2024
- Study completion6 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Atherothrombotic EventsStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298567
- Sponsor's protocol ID
- 21269
- Status last verified
- Jun 2024
- First submitted
- 19 Feb 2020
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04298567
- Acronym / sponsor ID
- 21269
- Conditions
- Prevention of Atherothrombotic Events, Coronary Artery Disease (CAD), Symptomatic Peripheral Artery Disease (Symptomatic PAD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 25 Feb 2022 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 6 Jun 2024 (actual)
- First posted
- 6 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | Drug: Rivaroxaban (Xarelto,Bay 59-7939), Drug: Acetylsalicylic acid(ASA)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivaroxaban (Xarelto,Bay 59-7939)Rivaroxaban (2.5 mg [BID]) | Drug | Treatment |
| Acetylsalicylic acid(ASA)ASA (75mg [QD]; dose according to local label. | Drug | Treatment |
Primary outcome
Number of participants with haemorrhagic events and complications
Time frame: Up to 13 months
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.
20 secondary outcomes
Number of participants with major adverse cardiovascular events (MACE)
Time frame: Up to 13 months
Number of participants with major adverse limb events (MALE)
Time frame: Up to 13 months
Number of participants with thromboembolic events
Time frame: Up to 13 months
Number of participants with cardiovascular mortality
Time frame: Up to 13 months
Number of participants with all-cause mortality
Time frame: Up to 13 months
Number of participants with cardiac revascularization procedures
Time frame: Up to 13 months
Number of participants with peripheral revascularization procedures
Time frame: Up to 13 months
Number of participants with carotid revascularization procedures
Time frame: Up to 13 months
Duration of hospitalizations
Time frame: Up to 13 months
Total and pain free walking distance per individual for PAD patients
Time frame: Change from baseline up to 13 months
Number of participants with history and diagnosis of CAD or PAD
Time frame: Up to 13 months
Number of participants with individual risk
Time frame: Up to 13 months
Number of participants with revascularization procedures and prior interventions (PCI, CABG), peripheral revascularization procedures
Time frame: Up to 13 months
Type of prior and concomitant antithrombotic treatment and other secondary prevention therapies in patients with CAD or PAD
Time frame: Up to 13 months
Dose of prior and concomitant antithrombotic treatment and other secondary prevention therapies in patients with CAD or PAD
Time frame: Up to 13 months
Duration of prior and concomitant antithrombotic treatment and other secondary prevention therapies in patients with CAD or PAD
Time frame: Up to 13 months
Reasons and decision points for introducing rivaroxaban 2.5 mg [BID]
Time frame: Up to 13 months
Reasons for discontinuation of rivaroxaban 2.5 mg [BID].
Time frame: Up to 13 months
Planned and actual duration of treatment with rivaroxaban 2.5 mg [BID].
Time frame: Up to 13 months
Planned and actual duration of treatment with ASA 75 mg [OD]
Time frame: Up to 13 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prevention of Atherothrombotic Events and Coronary Artery Disease (CAD), run by Bayer at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with haemorrhagic events and complications (time frame: Up to 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.