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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00501059
First received: July 12, 2007
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

The use of acetylsalicylic acid in the primary prevention of cardiovascular events has been extensively studied. However, the overall risk level of the study populations was low (< 10% 10-year CHD 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.


Condition Intervention Phase
Moderate Risk of CVD
Drug: Aspirin (Acetylsalicylic acid, BAYE4465)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Time to first occurrence of the composite outcome of MI, stroke, cardiovascular death, UA (unstable angina) or TIA (transient ischemic attack) [ Time Frame: Approximately 6 years of follow-up (duration of planned treatment phase) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first occurrence of the composite outcome of cardiovascular death, ACS (Acute Coronary Syndrome), or stroke [ Time Frame: Approximately 6 years of follow-up (duration of planned treatment phase) ] [ Designated as safety issue: No ]
  • Time to first occurrence of the individual components of the primary: non-fatal MI, total MI, non-fatal stroke, total stroke, cardiovascular death, UA or TIA [ Time Frame: Approximately 6 years of follow-up (duration of planned treatment phase) ] [ Designated as safety issue: No ]
  • Time to incidence of all cause mortality [ Time Frame: Approximately 6 years of follow-up (duration of planned treatment phase) ] [ Designated as safety issue: No ]
  • Time to first occurrence of/ incidence of all cancers, excluding non melanoma skin cancer [ Time Frame: Approximately 6 years of follow-up (duration of planned treatment phase) ] [ Designated as safety issue: No ]
  • Time to first occurrence of/ incidence of colon cancer [ Time Frame: Approximately 6 years of follow-up (duration of planned treatment phase) ] [ Designated as safety issue: No ]
  • Incidence of MI, stroke, UA, TIA and CV death separately [ Time Frame: Approximately 6 years of follow-up (duration of planned treatment phase) ] [ Designated as safety issue: No ]
  • Incidence of treatment-emergent adverse events (observed and reported), and changes in the physical examination findings, weight, and vital signs [ Time Frame: Approximately 56 years of follow-up (duration of planned treatment phase) ] [ Designated as safety issue: Yes ]

Enrollment: 12551
Study Start Date: July 2007
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Aspirin (Acetylsalicylic acid, BAYE4465)
100mg enteric coated Aspirin, taken daily
Placebo Comparator: Arm 2 Drug: Placebo
Placebo, taken daily

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males aged 55 years and above with 2 to 4 risk factors. Male Risk Factors:

    • Elevated cholesterol (Tchol>200 mg/dL or LDL>130 mg/dL; as measured at screening) irrespective of current treatment
    • Current smoking: defined as any cigarette smoking in the past 12 months
    • Low HDL cholesterol (HDL<40 mg/dL; as measured at screening)
    • Elevated blood pressure (SBP>140 mmHg; as measured at screening)
    • Currently on any medication to treat high blood pressure
    • Positive family history of early CHD (a first-degree relative [father, mother, brother, sister, son, daughter] suffered a heart attack [myocardial infarction] before the age of 60 years)
  • Females aged 60 and above with 3 or more risk factors. Female Risk Factors:

    • Elevated cholesterol (Tchol>240 mg/dL or LDL>160 mg/dL; as measured at screening) irrespective of current treatment
    • Current smoking: defined as any cigarette smoking in the past 12 months
    • Low HDL cholesterol (HDL<40 mg/dL; as measured at screening)
    • Elevated blood pressure (SBP>140 mmHg; as measured at screening)
    • Currently on any medication to treat high blood pressure
    • Positive family history of early CHD (a first-degree relative [father, mother, brother, sister, son, daughter] suffered a heart attack [myocardial infarction] before the age of 60 years)
  • An understanding and willingness to comply with trial procedures and has given written informed consent to participate in the trial

Exclusion Criteria:

  • History of a documented vascular event, such as MI, stroke, coronary artery angioplasty or stenting, coronary artery bypass graft, relevant arrhythmias, or congestive heart failure or vascular intervention
  • Patients who are at higher than moderate risk on the basis of their diabetes status, other factors known to the investigator, or the currently used national risk score
  • Known contraindications to the study drug, e.g. hypersensitivity to acetylsalicylic acid
  • Recent (in the past year) history of gastrointestinal or genitourinary bleeding or other bleeding disorders
  • Active diagnosed and documented reflux esophagitis
  • Patients presenting with any medical condition, or psychiatric or substance abuse disorder, that, in the opinion of the investigator, is likely to affect the patient's ability to complete the study or precludes the patient's participation in the study
  • Lactating women or women of childbearing potential
  • Severe liver disease or damage based on the clinical judgment of the investigator
  • Severe renal disease or damage based on the clinical judgement of the investigator
  • A definite indication for acetylsalicylic acid therapy, other antiplatelet drug, or anticoagulant in the opinion of the physician
  • A history of asthma induced by administration of salicylates or substances with a similar action, notably NSAIDS
  • Chronic, frequent (> 5 days/month) use of NSAIDs (including aspirin, or aspirin containing products), COX-2 inhibitors or metamizole
  • Current participation in any other trials involving investigational products within 30 days prior to the Screening Visit
  • Current use of an anticoagulant medication
  • Sitting systolic blood pressure greater than 170 mmHg
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00501059

  Show 669 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided by Bayer

Additional 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
Study First Received: July 12, 2007
Last Updated: March 25, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Ireland: Irish Medicines Board
Italy: Ethics Committee
Poland: Ministry of Health
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Bayer:
Primary prevention of coronary heart disease
Stroke and cardiovascular death
Aspirin

Additional relevant MeSH terms:
Cardiovascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 22, 2014