Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00501059
Status:
COMPLETED
Last Update Posted:
2018-10-26
First Post:
2007-07-12
Brief Title:
A Study to Assess the Efficacy and Safety of Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Multi-Center Parallel Group Study to Assess the Efficacy Reduction of Cardiovascular Disease Events and Safety of 100 mg Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease
Status:
COMPLETED
Status Verified Date:
2018-09
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:
ARRIVE
Brief Summary:
The use of acetylsalicylic acid in the primary prevention of cardiovascular events has been extensively studied but to a lesser extent in patients with moderate levels of cardiovascular risk The current study is designed to prove the efficacy and tolerability of 100 mg enteric-coated Aspirin versus placebo in the prevention of cardiovascular disease CVD events which include fatal and nonfatal myocardial infarction fatal and nonfatal stroke and CV death in a population with no history of known CVD who are at moderate risk of major CHD events approximately 10-20 10 year CHD risk This corresponds to a patient population mean 10-year CVD risk of approximately 30 Subjects are treated in a standard care setting and may receive treatment for the underlying risk factors as defined by the treating physician Outcome events will be adjudicated by an Endpoint Adjudication Committee and the study will be monitored by an independent Data Safety Monitoring Board
Detailed Description:
Summary of substantial Protocol amendments
Amendment 2 from 09-APR-2008
Systolic blood pressure SBP limit of 170 mmHg has been added to the exclusion criteria
Exclusion of patients currently taking anticoagulant medication
A longer interval between the daily dose of study drug and ibuprofen
Revised wording in moderate risk definitions for coronary heart disease CHD and cerebrovascular disease CVD To evaluate the clinical effects of a 100 mgday enteric-coated acetylsalicylic acid versus placebo in the reduction of CVD events in patients at moderate risk of major CHD events approximately 10 to 20 10-year CHD risk approximately 20 to 30 10-year risk of CVD This corresponds to a patient population mean 10-year CVD risk of approximately 30
Amendment 3 from 02-JAN-2009
Increase in the number of allowed risk factors for males age is no longer a risk factor
Amendment 4 from 02-OCT-2013
The primary endpoint is changed to include confirmed UA and TIA
The estimated event rate is changed to 15 per year due to new information
Effect size risk reduction changed from 149 to 17 to 18
Achieving 60000 person-years instead of 1488 primary endpoint events
Additional treatment and follow-up for a maximum of another 12 months
Change to reduced adverse event and concomitant therapy reporting
Amendment 2 from 09-APR-2008
Systolic blood pressure SBP limit of 170 mmHg has been added to the exclusion criteria
Exclusion of patients currently taking anticoagulant medication
A longer interval between the daily dose of study drug and ibuprofen
Revised wording in moderate risk definitions for coronary heart disease CHD and cerebrovascular disease CVD To evaluate the clinical effects of a 100 mgday enteric-coated acetylsalicylic acid versus placebo in the reduction of CVD events in patients at moderate risk of major CHD events approximately 10 to 20 10-year CHD risk approximately 20 to 30 10-year risk of CVD This corresponds to a patient population mean 10-year CVD risk of approximately 30
Amendment 3 from 02-JAN-2009
Increase in the number of allowed risk factors for males age is no longer a risk factor
Amendment 4 from 02-OCT-2013
The primary endpoint is changed to include confirmed UA and TIA
The estimated event rate is changed to 15 per year due to new information
Effect size risk reduction changed from 149 to 17 to 18
Achieving 60000 person-years instead of 1488 primary endpoint events
Additional treatment and follow-up for a maximum of another 12 months
Change to reduced adverse event and concomitant therapy reporting
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-003622-29 | EUDRACT_NUMBER | None | None |