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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01000727
Other study ID # 480848/033
Secondary ID
Status Completed
Phase Phase 3
First received October 22, 2009
Last updated March 21, 2017
Start date December 2009
Est. completion date April 2014

Study information

Verified date March 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 13026
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Darapladib 160 mg
Lp-PLA2 inhibitor
Placebo
Placebo administered
Other:
Standard Therapy
Guideline mandated therapy for individual's condition

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Sponsors (2)

Lead Sponsor Collaborator
GlaxoSmithKline The TIMI Study Group

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Colombia,  Czech Republic,  Denmark,  France,  Germany,  Hungary,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  New Zealand,  Peru,  Philippines,  Poland,  Romania,  Russian Federation,  Slovakia,  South Africa,  Spain,  Sweden,  Taiwan,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to the first occurrence of any component of the composite of major coronary events (i.e., Coronary Heart Disease (CHD) death, non-fatal myocardial infarction (MI), or urgent coronary revascularization for myocardial ischemia). Up to 5 years.
Secondary The composite measure of Major Adverse Cardiovascular Event (MACE) that includes cardiovascular (CV) death (death due to a cardiovascular cause), non-fatal MI, or non-fatal stroke. Up to 1400 days.
Secondary Individual components of MACE (CV death, MI (fatal and non-fatal), stroke (fatal and non-fatal)). Up to 1400 days.
Secondary Individual components of major coronary events (CHD death, MI (fatal and non-fatal), urgent coronary revascularization for myocardial ischemia). Up to 1400 days.
Secondary Composite measure of total coronary events that incl. first occurrence of CHD death, non-fatal MI, hosp. for unstable angina(UA), or any coronary revasc. proc.(excl. percutaneous coronary intervention(PCI) planned prior to but performed after rand.). Up to 1400 days.
Secondary Any coronary revascularization procedures (excluding PCI planned prior to randomization but performed after randomization). Up to 1400 days.
Secondary The first occurrence of any component of the composite of all-cause mortality, non-fatal MI, or non-fatal stroke. Up to 1400 days.
Secondary The composite of CHD death and non-fatal MI. Up to 1400 days.
Secondary All cause mortality. Up to 1400 days.
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