A Study to Assess the Efficacy and Safety of Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00501059

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 III

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:

Drug Information available for: Acetylsalicylic acid

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Time to first occurrence of the composite outcome of MI, stroke or cardiovascular death [ Time Frame: Approximately 5 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 5 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 or cardiovascular death [ Time Frame: Approximately 5 years of follow-up (duration of planned treatment phase) ] [ Designated as safety issue: No ]
Time to incidence of all cause mortality [ Time Frame: Approximately 5 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 5 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 5 years of follow-up (duration of planned treatment phase) ] [ Designated as safety issue: No ]
Incidence of MI, stroke and CV death separately [ Time Frame: Approximately 5 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 5 years of follow-up (duration of planned treatment phase) ] [ Designated as safety issue: Yes ]

Enrollment:	12587
Study Start Date:	July 2007
Estimated Study Completion Date:	May 2015
Estimated Primary Completion Date:	May 2015 (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 666 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

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No publications provided

Responsible Party:	Head Clinical and Medical Affairs, Bayer Consumer Care Inc.
ClinicalTrials.gov Identifier:	NCT00501059 History of Changes
Other Study ID Numbers:	12198, 2006-003622-29
Study First Received:	July 12, 2007
Last Updated:	January 18, 2012
Health Authority:	United States: Food and Drug Administration

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 February 09, 2012