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

Sponsor:	GlaxoSmithKline
Collaborator:	The TIMI Study Group
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01000727

Purpose

This study will test whether darapladib can safely lower the chances of having a cardiovascular event (such as a heart attack or stroke) when treatment is started within 30 days after an acute coronary syndrome (also called ACS).

Condition	Intervention	Phase
Atherosclerosis Acute Coronary Syndrome Cardiovascular Disease Coronary Heart Disease	Drug: Darapladib 160 mg Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects Following Acute Coronary Syndrome to Compare the Incidence of Major Adverse Cardiovascular Events (MACE).

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis Coronary Artery Disease Heart Attack Heart Diseases

Drug Information available for: Darapladib

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Time to the first occurrence of any component of the composite of Major Adverse Cardiovascular Events [MACE: CV death (death due to a cardiovascular cause), non-fatal myocardial infarction, non-fatal stroke]. [ Time Frame: Through the end of the study. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The composite measure of major coronary events that include the first occurrence of coronary heart disease death, non-fatal myocardial infarction or urgent coronary revascularization for myocardial ischemia. [ Time Frame: Through the end of the study. ] [ Designated as safety issue: No ]
The composite measure of total coronary events that include the first occurrence of coronary heart disease death, non-fatal MI, hospitalization for UA, or any coronary revasc procedure (excluding PCI planned prior to but performed after randomization). [ Time Frame: Through the end of the study. ] [ Designated as safety issue: No ]
The individual components of MACE [cardiovascular death, myocardial infarction (fatal and non-fatal), stroke (fatal and non-fatal)]. [ Time Frame: Through the end of the study. ] [ Designated as safety issue: No ]
The first occurrence of any component of the composite of all-cause mortality, non-fatal myocardial infarction, or non-fatal stroke. [ Time Frame: Through the end of the study. ] [ Designated as safety issue: No ]
All cause mortality. [ Time Frame: Through the end of the study. ] [ Designated as safety issue: No ]

Estimated Enrollment:	13000
Study Start Date:	December 2009
Estimated Study Completion Date:	April 2014
Estimated Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Darapladib 160 mg Single daily oral tablet	Drug: Darapladib 160 mg Lp-PLA2 inhibitor administered in addition to standard therapy. Other Name: SB-480848
Placebo Comparator: Placebo Single daily oral tablet	Drug: Placebo Placebo administered in addition to standard therapy.

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01000727

Show 905 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

The TIMI Study Group

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

O'Donoghue ML, Braunwald E, White HD, Serruys P, Steg PG, Hochman J, Maggioni AP, Bode C, Weaver D, Johnson JL, Cicconetti G, Lukas MA, Tarka E, Cannon CP. Study design and rationale for the Stabilization of pLaques usIng Darapladib-Thrombolysis in Myocardial Infarction (SOLID-TIMI 52) trial in patients after an acute coronary syndrome. Am Heart J. 2011 Oct;162(4):613-619.e1. Epub 2011 Sep 15.

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT01000727 History of Changes
Other Study ID Numbers:	480848/033
Study First Received:	October 22, 2009
Last Updated:	January 26, 2012
Health Authority:	Spain: Agencia Espanola de Medicamentos y Productos Sanitarios; Slovakia: State Institute for Drug Control; Estonia: State Agency of Medicines; Colombia: INVIMA; Chile: Institutional Review Board; Brazil: Institutional Review Board; Peru: Institutional Review Board; Greece: National Ethics Committee; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Italy: Comitato Etico Unico per la Provincia di Parma - Via Gramsci, 14- 43100 Parma; Belgium: Federal Agency for Medicinal Products and Health Products; Bulgaria: The Bulgarian Drug Agency; Argentina: Ministry of Health - A.N.M.A.T; Romania: Agentia Nationala a Medicamentului; Ukraine: The Central Ethics Committee of Ministry of Health of Ukraine; Japan: Pharmaceutical and Medical Device Agency; Russia: Federal Service of Surveillance in Healthcare and Social development of Russian federation; Norway: Statens Legemiddelverk; Taiwan: Department of Health; India: Drugs Controller General of India; Thailand: Ministry of Public Health; Philippines: Bureau of Food and Drugs; Hungary: Országos Gyógyszerészeti Intézet; South Africa: Medicines Control Council; Poland: URZ.D REJESTRACJI PRODUKTÓW LECZNICZYCH, WYROBÓW MEDYCZNYCH I PRODUKTÓW BIOBÓJCZYCH,CEBK; Mexico: Ministry of Health; New Zealand: Medicines and Medical Devices Safety Authority; Denmark: Danish Medicines Agency; France: Agence Française de Sécurité Sanitaire des Produits de Santé; Germany: Federal Institute for Drugs and Medical Devices; Netherlands: De Centrale Commissie Mensgebonden Onderzoek; Israel: Ministry of Health; Czech: State Institute for Drug Control; China: State Food and Drug Administration; South Korea: Food and Drug Administration; United States: Food and Drug Administration; Sweden: Läkemedelsverket; Turkey: Ministry of Health; Australia: Therapeutic Goods Administration; Greece: National Drug Organisation

Keywords provided by GlaxoSmithKline:

Atherosclerosis
Heart disease
Cardiovascular disease
Lp-PLA2 inhibitor

The TIMI Study Group
Coronary Heart Disease (CHD)
Acute Coronary Syndrome (ACS)

Additional relevant MeSH terms:

Atherosclerosis
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Myocardial Infarction
Acute Coronary Syndrome

Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012