The Stabilization Of pLaques usIng Darapladib-Thrombolysis In Myocardial Infarction 52 Trial



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/25/2017
Start Date:December 2009
End Date:April 2014

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A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects Following Acute Coronary Syndrome to Compare the Incidence of Major Adverse Cardiovascular Events (MACE).

This study will test whether darapladib can safely lower the chances of having a
cardiovascular event (such as a heart attack or urgent coronary revascularization (e.g.
medical procedures performed to restore the normal blood flow in patients with
atherosclerosis)) when treatment is started within 30 days after an acute coronary syndrome
(also called ACS).

Subjects who qualify for the study will be randomized 1:1 to either darapladib or placebo
administered in addition to standard therapy. Following the baseline visit, subjects will be
expected to return for clinic visits at 1 month, 3 months, 6 months and every 6 months until
the end of the study.

Inclusion Criteria:

- Signed written informed consent.

- Men or women at least 18 years old (in Taiwan, at least 20 years old). Women must be
post-menopausal or using a highly effective method for avoidance of pregnancy.

- Hospitalization for acute coronary syndrome (ACS) within 30 days prior to study
entry.

- Clinically stable for 24 hours prior to study entry.

- A planned percutaneous coronary intervention (PCI) should be performed prior to study
entry, whenever possible.

- At least one of the following:

- At least 60 years old.

- Myocardial infarction prior to the qualifying ACS event.

- Diabetes mellitus requiring treatment with medication.

- Diagnosed mild or moderate reduction in kidney function.

- Cerebrovascular disease (carotid artery disease or ischemic stroke more than 3 months
prior to study entry) OR peripheral artery disease.

Exclusion Criteria:

- ACS symptoms or lab results not believed to be caused by a narrowing or blocked
coronary artery.

- No major coronary artery with a blockage of more than 50% (unless all stenoses are
successfully treated by PCI).

- Planned coronary artery bypass graft (CABG) surgery, or CABG surgery performed after
the qualifying ACS event and prior to study entry.

- Certain types of liver disease.

- Severe reduction in kidney function OR removal of a kidney OR kidney transplant.

- Severe heart failure.

- Blood pressure higher than normal despite lifestyle changes and treatment with
medications.

- Any life-threatening disease with a life expectancy of less than 2 years (other than
heart disease) that may prevent the subject from completing the study.

- Severe asthma that is poorly controlled with medication.

- Pregnancy (Note: A pregnancy test will be performed on all non-sterile women prior to
study entry).

- Previous severe allergic reaction to food, medications, drink, insect stings, etc.

- Drug or alcohol abuse within the past 6 months. Mental/psychological impairment that
may prevent the subject from complying with study procedures or understanding the
goal and potential risks of participating in the study.

- Certain medications that may interfere with the study medication (these will be
identified by the study doctor).

- If both birth parents are at least 50% Japanese, Chinese, or Korean ancestry, must
have a blood sample collected for Lp-PLA2 activity. Those with Lp-PLA2 activity less
than or equal to 20.0 nmol/min/mL are excluded.

- Previously took darapladib (SB-480848).

- Participation in a study of an investigational medication within the past 30 days.

- Current participation in a study of an investigational device.

- Any other reason the investigator deems the subject should not participate in the
study.
We found this trial at
259
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Los Alamitos, California 90720
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Albany, New York 12206
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Albuquerque, New Mexico 87109
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Alexandria, Louisiana 71301
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Allentown, Pennsylvania 18102
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Amarillo, Texas 79106
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Anchorage, Alaska 99508
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Ann Arbor, Michigan 48109
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Asheville, North Carolina 28803
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Atlanta, Georgia 30341
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Atlantis, Florida 33462
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Augusta, Georgia 30909
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Aurora, Illinois 60504
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Austin, Texas 78705
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Aventura, Florida 33180
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Avon, Indiana 46123
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Ayer, Massachusetts 01432
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Bakersfield, California 93309
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Baltimore, Maryland 21201
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Bangor, Maine 04401
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Bannockburn, Illinois 60015
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Bel Air, Maryland 21014
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Bellevue, Washington 98004
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Bellingham, Washington 98225
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Beloit, Wisconsin 53511
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Bethlehem, Pennsylvania 18105
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Beverly Hills, California 90211
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Birmingham, Alabama 35249
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Boise, Idaho 83712
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Bridgeport, Connecticut 06606
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Bronx, New York 10461
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Brooklyn, New York 11215
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Browns Mills, New Jersey 08015
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Buffalo, New York 14263
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Burien, Washington 98166
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Burlington, North Carolina 27215
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Chambersburg, Pennsylvania 17201
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Chattanooga, Tennessee 37421
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Chicago, Illinois 60611
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Columbia, South Carolina 29203
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Columbia, Tennessee 38401
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Concord, North Carolina 28025
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Corpus Christi/Texas, Texas 78404
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Cortlandt Manor, New York 10567
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Crestview Hill, Kentucky 41017
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Fort Lauderdale, Florida 33308
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