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A Study to Assess the Efficacy and Safety of Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease (ARRIVE)

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ClinicalTrials.gov Identifier: NCT00501059
Recruitment Status : Completed
First Posted : July 13, 2007
Results First Posted : January 8, 2018
Last Update Posted : January 8, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Moderate Risk of CVD
Interventions: Drug: Aspirin (Acetylsalicylic acid, BAYE4465)
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Overall, 15823 subjects were screened. Of these, 3277 subjects were screening failures. The remaining 12546 subjects were randomized to treatment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Acetylsalicylic Acid (Aspirin, BAYE4465) Subjects received 1 tablet of enteric-coated acetylsalicylic acid [100 milligram (mg)] orally once daily.
Placebo Subjects received 1 tablets of matching placebo orally once daily.

Participant Flow:   Overall Study
    Acetylsalicylic Acid (Aspirin, BAYE4465)   Placebo
STARTED   6270   6276 
COMPLETED   4402   4384 
NOT COMPLETED   1868   1892 
Protocol Violation                80                69 
Death                140                137 
Other                236                239 
Missing end-of-study page                91                92 
Clinical endpoint reached                110                123 
Insufficient therapeutic effect                4                5 
Consent withdrawn by subject                817                873 
Non-compliant with study treatment                23                16 
Reason not given                3                1 
Adverse Event                129                122 
Lost to Follow-up                210                198 
Not treated                25                17 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Acetylsalicylic Acid (Aspirin, BAYE4465) Subjects received 1 tablet of enteric-coated acetylsalicylic acid [100 milligram (mg)] orally once daily.
Placebo Subjects received 1 tablets of matching placebo orally once daily.
Total Total of all reporting groups

Baseline Measures
   Acetylsalicylic Acid (Aspirin, BAYE4465)   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 6270   6276   12546 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.9  (7.10)   63.9  (7.05)   63.9  (7.08) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1851  29.5%      1857  29.6%      3708  29.6% 
Male      4419  70.5%      4419  70.4%      8838  70.4% 


  Outcome Measures

1.  Primary:   Time to the First Occurrence of the Composite Outcome of MI (Myocardial Infarction), Stroke, Cardiovascular Death, UA (Unstable Angina) or TIA (Transient Ischemic Attack)   [ Time Frame: Until follow-up (approximate 6 years) ]

2.  Secondary:   Time to the First Occurrence of the Composite Outcome of Cardiovascular Death, MI, or Stroke (Ischemic, Hemorrhagic, or Unknown)   [ Time Frame: Until follow-up (approximate 6 years) ]

3.  Secondary:   Time to the First Occurrence of the Individual Components of the Primary: Non-fatal MI, Total MI, Non-fatal Stroke, Total Stroke, Cardiovascular Death, UA and TIA   [ Time Frame: Until follow-up (approximately 6 years) ]

4.  Secondary:   Time to All-cause Mortality, the First Occurrence of All Cancers Excluding Non-melanoma Skin Cancer (NMSC) and the First Occurrence of Colon Cancer   [ Time Frame: Until follow-up (approximately 6 years) ]

5.  Secondary:   Incidence of All-cause Mortality, All Cancers Excluding Non-melanoma Skin Cancer and Colon Cancer   [ Time Frame: Until follow-up (approximately 6 years) ]

6.  Secondary:   Incidence of Confirmed MI, Stroke, Cardiovascular Death, UA, and TIA Separately   [ Time Frame: Until follow-up (approximately 6 years) ]

7.  Other Pre-specified:   Number of Subjects With Adjudicated GI Bleeding by Severity   [ Time Frame: Until follow-up (approximate 6 years) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The reported analyses are limited to endpoint events that met strict criteria. Further blinded review of events is ongoing to identify endpoints based on pragmatic criteria. Interpretations for clinical decision making should await future reporting.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayer.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00501059     History of Changes
Other Study ID Numbers: 12198
2006-003622-29 ( EudraCT Number )
First Submitted: July 12, 2007
First Posted: July 13, 2007
Results First Submitted: November 15, 2017
Results First Posted: January 8, 2018
Last Update Posted: January 8, 2018