Trial record 1 of 2 for:    SOLID-TIMI 52
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The Stabilization Of pLaques usIng Darapladib-Thrombolysis In Myocardial Infarction 52 Trial (SOLID-TIMI 52)

This study has been completed.
Sponsor:
Collaborator:
The TIMI Study Group
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01000727
First received: October 22, 2009
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

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).


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:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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). [ Time Frame: Up to 5 years. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: Up to 1400 days. ] [ Designated as safety issue: No ]
  • Individual components of MACE (CV death, MI (fatal and non-fatal), stroke (fatal and non-fatal)). [ Time Frame: Up to 1400 days. ] [ Designated as safety issue: No ]
  • Individual components of major coronary events (CHD death, MI (fatal and non-fatal), urgent coronary revascularization for myocardial ischemia). [ Time Frame: Up to 1400 days. ] [ Designated as safety issue: No ]
  • 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.). [ Time Frame: Up to 1400 days. ] [ Designated as safety issue: No ]
  • Any coronary revascularization procedures (excluding PCI planned prior to randomization but performed after randomization). [ Time Frame: Up to 1400 days. ] [ Designated as safety issue: No ]
  • The first occurrence of any component of the composite of all-cause mortality, non-fatal MI, or non-fatal stroke. [ Time Frame: Up to 1400 days. ] [ Designated as safety issue: No ]
  • The composite of CHD death and non-fatal MI. [ Time Frame: Up to 1400 days. ] [ Designated as safety issue: No ]
  • All cause mortality. [ Time Frame: Up to 1400 days. ] [ Designated as safety issue: No ]

Enrollment: 13026
Study Start Date: December 2009
Study Completion Date: April 2014
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 916 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: May 22, 2014
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
Darapladib
Phospholipase A2 Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014