Ignite Creation Date:
2024-05-06 @ 2:21 PM
Last Modification Date:
2024-10-26 @ 1:30 PM
Study NCT ID:
NCT04298567
Status:
COMPLETED
Last Update Posted:
2024-06-28
First Post:
2020-02-19
Brief Title:
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 andor With Reduced Blood Flow in the Arteries of the Legs and Arms With Symptoms Symptomatic PAD
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
A Phase IV Study to Investigate the Safety and Effectiveness of RivaroxabanXarelto 25mg BIDAcetylsalicylic AcidASA 75mg OD in Indian Patients With Coronary andor Symptomatic Peripheral Artery Disease
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None