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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


Phase 3
55 Years
N/A
Open (Enrolling)
Both
Moderate Risk of CVD

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to first occurrence of the composite outcome of MI, stroke or cardiovascular death

Outcome Time Frame:

Approximately 5 years of follow-up (duration of planned treatment phase)

Safety Issue:

No

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

United States: Food and Drug Administration

Study ID:

12198

NCT ID:

NCT00501059

Start Date:

July 2007

Completion Date:

May 2015

Related Keywords:

  • Moderate Risk of CVD
  • Primary prevention of coronary heart disease
  • Stroke and cardiovascular death
  • Aspirin
  • Cardiovascular Diseases

Name

Location

Hinsdale, Illinois  60521
Bettendorf, Iowa  52722
Albany, Georgia  31701
Birmingham, Alabama  35294
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Flint, Michigan  48532
Louisville, Kentucky  40207
McLean, Virginia  22101
Little Rock, Arkansas  72205-7199
Scarborough, Maine  04074
Omaha, Nebraska  68114
Hackensack, New Jersey  07601
Metairie, Louisiana  70006
Baltimore, Maryland  21287
Boston, Massachusetts  
Charlotte, North Carolina  
Eugene, Oregon  
Milwaukee, Wisconsin  
Wilmington, Delaware  
Indianapolis, Indiana  
Charleston, South Carolina  
Tulsa, Oklahoma  
Providence, Rhode Island  02908
Jackson, Mississippi  
Salt Lake City, Utah  84112