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View Clinical Trial (Medical Research Study)
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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 - NCT00501059-53218 (Clinical Trial 177015)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy177015.aspx
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| City: |
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Milwaukee |
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State:
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WI |
| Zip Code: |
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53218 |
| Conditions: |
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Moderate Risk of CVD |
| Purpose: |
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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). The current study is designed to proof 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 (20-30%
10-year) of cardiovascular disease. Subjects are treated in a standard care setting and may
receive treatment of 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.
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| Study summary: |
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| Criteria: |
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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:
- Clinical history of CVD, MI, stroke, coronary artery angioplasty or stenting,
coronary artery bypass graft, relevant arrhythmias, or congestive heart failure or
- 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
- Increased risk of bleeding or gastric or duodenal ulcer, or current /diagnosed 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 patients
ability to complete the study or precludes the patients participation in the study
- Lactating women or women of childbearing potential
- Severe liver disease or damage, or moderately impaired renal function based on the
clinical judgment of the investigator
- A definite indication for acetylsalicylic acid therapy, other anti-platelet drug, or
anticoagulant in the opinion of the physician
- A history of asthma induced by administration of salicylates or substances with
similar action, notably NSAIDS
- Chronic, frequent (> 5 days/month) use of NSAIDs, COX 2 inhibitors or metamizole, or
current participation in any other trials involving investigational products within
30 days prior to the Screening Visit |
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| Study is available at: |
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Milwaukee, WI 53218
United States
Primary Contact:
Bayer Clinical Trials Contact
Email: clinical-trials-contact@bayerhealthcare.com |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 16, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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