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The Stabilization Of pLaques usIng Darapladib-Thrombolysis In Myocardial Infarction 52 Trial (SOLID-TIMI 52)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The TIMI Study Group
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01000727
First received: October 22, 2009
Last updated: June 12, 2013
Last verified: May 2013
History of Changes
  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
Acute Coronary Syndrome
 Drug: Darapladib 160 mg
Drug: Placebo
 Phase 3

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:

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: March 2014
Estimated Primary Completion Date: March 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 839 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):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01000727     History of Changes
Other Study ID Numbers: 480848/033
Study First Received: October 22, 2009
Last Updated: June 12, 2013
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: 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:
Myocardial Infarction
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
 Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013