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Trial record 1 of 1 for:    NCT00910962
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A Study to Evaluate the Safety of 12 Weeks of Dosing With GW856553 and Its Effects on Inflammatory Markers, Infarct Size, and Cardiac Function in Subjects With Myocardial Infarction Without ST-segment Elevation (Solstice)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00910962
First Posted: June 1, 2009
Last Update Posted: December 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
This is a randomized, double-blind, placebo-controlled, parallel group, multi-center study to evaluate initial safety and efficacy of GW856553 in subjects with NSTEMI. Up to approximately 525 subjects will be randomized to meet the MRI recruitment target (90 subjects in substudy.) All subjects will continue to receive the local standard of care for the duration of the study.

Condition Intervention Phase
Acute Coronary Syndrome Drug: GW856553 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of 12 Weeks of Dosing With GW856553 and Its Effects on Inflammatory Markers, Infarct Size, and Cardiac Function in Subjects With Myocardial Infarction Without ST-segment Elevation

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Week 14 ]
    AE was any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.

  • Number of Participants With Any Major Adverse Cardiovascular Events (MACE) [ Time Frame: Up to Week 14 ]
    MACE was defined as all-cause death, adjudicated myocardial infarction, stroke/transient ischemic attack, heart failure or recurrent ischemia requiring urgent revascularization.

  • Number of Participants With Any Pure MACE [ Time Frame: Up to Week 14 ]
    Pure MACE was defined as all-cause death, adjudicated myocardial infarction or stroke/transient ischemic attack.

  • Number of Participants With Hematology Data of Potential Clinical Importance (PCI) at Any Visit Post-Baseline [ Time Frame: Up to Week 14 ]
    Hematology parameters (PCI range): Eosinophils (<0.045 or >0.605 Giga cells per liter [GI/L]), Hematocrit (<0.297 or >0.506 ratio), Hemoglobin (<85 or >200 grams per liter [g/L]), Lymphocytes (<0.765 or >4.51GI/L), Mean Corpuscle Hemoglobin (MCH) (<24.3 or >38.5 picograms [PG]), Mean Corpuscle Hemoglobin Concentration (MCHC) (<256 or >432 g/L), Mean Corpuscle Volume (MCV) (<70 or >115 femtoliter [FL]), Monocytes (<0.18 or >1.21 GI/L), Platelet count (<104 or >480 GI/L), Red Cell Distribution Width (RDW) (<7.2 or >18%), Red Blood Cell (RBC) count (<2.88 or >6.12 trillion per liter [TI/L] for females and <3.52 or >6.96 TI/L for males) , Reticulocytes (<22.5 or >93.5 10^9/L), Total Absolute Neutrophil Count (ANC) (<1.62 or >8.8 GI/L), White Blood Cell (WBC) count (<3.04 or >12 GI/L) were analyzed. The data was presented as High and low, at any visit post-Baseline. Only parameters with observed abnormal values were presented.

  • Number of Participants With Clinical Chemistry Data of PCI at Any Visit Post-Baseline [ Time Frame: Up to Week 14 ]
    Clinical chemistry parameters (PCI range): Alanine Amino Transferase (ALT) (>=3x upper limit normal [ULN] units per liter [U/L]), Albumin (<25.6 or >60 g/L), Alkaline Phosphatase (>=2x ULN U/L), Aspartate Amino Transferase (AST) (>=3x ULN U/L), Calcium (<2.0776 or >2.6112 millimoles per liter [mmol/L]), Carbon dioxide content/Bicarbonate (CO2/HCO3) (<19.6 or >32.64 mmol/L), Chloride (<93.1 or >110.16 mmol/L), Creatinine (<39.6 or >136.4 micromole per liter [µmol/L]) , Glucose (<3.51 or >6.05 mmol/L), Potassium (<3.43 or >5.406 mmol/L), Sodium (<132.3 or >148.92 mmol/L), Total Bilirubin (T. bilirubin) (>=1.5xULN µmol/L) , Total Protein (<50 or >95 g/L), Urea/Blood urea nitrogen (BUN) (<2.25 or >11.55 mmol/L) and Uric acid (<135 or >495 µmol/L) were analyzed. The data was presented as High and low, at any visit post-Baseline. Only parameters with observed abnormal values were presented.

  • Number of Participants With Liver Function Test Elevations at Any Time Post-Baseline [ Time Frame: Up to Week 14 ]
    Liver function test parameters: Alanine aminotransferase (ALT), Total Bilirubin (T. Bilirubin), Aspartate aminotransferase (AST), Alkaline Phosphatase, Gamma glutamyl transferase (GGT) and Creatine Kinase were analyzed and presented as elevated test values at any time post-Baseline. The elevations were presented as >=2xULN, >=3xULN, >=5xULN, >=10xULN, and >=20xULN. n= number of participants with at least one non-missing result of the particular lab test post-Baseline.

  • Number of Participants With Abnormal Electrocardiogram (ECG) Findings at Any Time Post-Baseline [ Time Frame: Up to Week 14 ]
    A single 12-lead ECG was obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT corrected (QTc) intervals. ECG findings were presented as Normal, Abnormal - Not clinically significant and Abnormal - Clinically significant at any time post-Baseline.

  • Number of Participants With Vital Signs of PCI at Any Visit Post-Baseline [ Time Frame: Up to Week 14 ]
    Vital signs (PCI range): Systolic blood pressure (SBP) (<75 and >200 millimeter of mercury [mmHg]), Diastolic blood pressure (DBP) (<40 and >120 mmHg) and Heart rate (<30 and >200 beats per minute [bpm]) were analyzed and were presented at any visit post-Baseline. Participants with both Normal and Low values were counted once under their worst case (Low). Participants with both Normal and High values were counted once under their worst case (High). Participants with both High and Low values were counted under both categories. All heart rate values were within normal range, hence not presented.

  • Mean High-sensitive C-Reactive Protein (hsCRP) Value at Week 12 [ Time Frame: At Week 12 ]
    Analysis of hsCRP included all participants who provided data at Baseline and at least one post-Baseline measure. Statistical analyses was performed to compare hsCRP levels between study drug and placebo. Log transformed ratio to Baseline hsCRP was analyzed using repeated measures analysis of covariance (ANCOVA) including a term for treatment, adjusting for Baseline hsCRP as a covariate, and accounting for other covariates as appropriate to the study design.

  • Mean Cardiac Troponin I (cTnI) Area Under Concentration-time Curve (AUC) Over 72 Hours Post-randomization or Until Hospital Discharge (Whichever Comes First) [ Time Frame: At pre-dose and at 8, 16, 24, 32, 40, 48, 56, 64 and 72 hours ]
    cTnI AUC was the average concentration of cTnI during hospital stay. Statistical analyses was performed to compare cTnI levels between study drug and placebo, via ANCOVA.


Secondary Outcome Measures:
  • Mean hsCRP Over Hospitalization Period and Through Week 14 [ Time Frame: Up to Week 14 ]
    Analysis of hsCRP included all participants who provided data at Baseline and at least one post-Baseline measure. The sample had a collection window of +/- 8 hours. Statistical analyses was performed to compare hsCRP levels between study drug and placebo. Log transformed ratio to Baseline hsCRP was analyzed using ANCOVA including a term for treatment, adjusting for Baseline hsCRP as a covariate, and accounting for other covariates as appropriate to the study design.

  • Mean Interleukin-6 (IL-6) Value at 24 Hours Post-randomization and at Weeks 2 and 12 [ Time Frame: 24 hours post-randomization and at Weeks 2 and 12 ]
    Statistical analyses was performed to compare IL-6 levels between study drug and placebo. Log transformed ratio to Baseline IL-6 was analyzed using repeated measures ANCOVA including a term for treatment, adjusting for Baseline IL-6 as a covariate, and accounting for other covariates as appropriate to the study design.

  • Mean Creatine Kinase (MB Isoenzyme) (CK-MB) AUC Over 72 Hours Post-randomization or Until Hospital Discharge (Whichever Comes First) [ Time Frame: At pre-dose and at hours 8, 16, 24, 32, 40, 48, 56, 64 and 72 ]
    Statistical analyses was performed to compare CK-MB levels between study drug and placebo. Log transformed ratio to Baseline CK-MB was analyzed using repeated measures ANCOVA including a term for treatment, adjusting for Baseline CK-MB as a covariate, and accounting for other covariates as appropriate to the study design.

  • Peak cTnI Over 72 Hours Post-randomization or Until Hospital Discharge (Whichever Comes First) [ Time Frame: Up to 72 hours ]
    Statistical analyses was performed to compare cTnI levels between study drug and placebo. Log transformed ratio to Baseline cTnI was analyzed using repeated measures ANCOVA including a term for treatment, adjusting for Baseline cTnI as a covariate, and accounting for other covariates as appropriate to the study design.

  • Mean Brain Natriuretic Peptide (BNP) at Discharge and Week 12 [ Time Frame: At discharge and Week 12 ]
    Statistical analyses was performed to compare BNP levels between study drug and placebo. Log transformed ratio to Baseline BNP was analyzed using repeated measures ANCOVA including a term for treatment, adjusting for Baseline BNP as a covariate, and accounting for other covariates as appropriate to the study design.

  • Mean Infarct Size Prior to Discharge From Hospital (Approximately Day 3) and at Week 12 [ Time Frame: Prior to discharge (visit 1) and at Week 12 ]
    Statistical analyses was performed to compare the infarct size (via MRI) at Week 12 via repeated measures ANOVA between study drug and placebo using Bayesian methods for inference. Myocardial infarct size was measured by delayed enhancement magnetic resonance imaging (MRI) as: Infarct size (% of left ventricular myocardium [% of LV]) for infarct 1. The infarct region 1 was the infarct region which the MRI interpretation process identified as the primary infarct region of the index hospitalization. Participants were included in the analyses, provided they have data for derivation of the measures of interest (MR infarct size). A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing.

  • Mean Percent Left Ventricular Ejection Fraction (LVEF) at Week 12 [ Time Frame: At Week 12 ]
    Statistical analyses of the treatment differences was performed to compare the LVEF (via MRI) at Week 12, and for the change from Day 3 to Week 12 via repeated measures ANCOVA between study drug and placebo. Cardiac MRIs were performed at qualified sites on participants who agree to participate in the MRI sub-study. A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing.

  • Mean Left Ventricular End-diastolic Volume (LVEDV) and Left Ventricular End-systolic Volume (LVESV) at Week 12 [ Time Frame: At Week 12 ]
    Statistical analyses of the treatment differences was performed to compare the LVEDV and LVESV (via MRI) at Week 12, and for the change from Day 3 to Week 12 via repeated measures ANCOVA between study drug and placebo. Cardiac MRIs were performed at qualified sites on participants who agree to participate in the MRI sub-study. A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing.

  • Mean Left Ventricular Mass at Week 12 [ Time Frame: At Week 12 ]
    Statistical analyses of the treatment differences was performed to compare the left ventricular mass (via MRI) at Week 12, and for the change from Day 3 to Week 12 via repeated measures ANCOVA between study drug and placebo.Cardiac MRIs were performed at qualified sites on participants who agree to participate in the MRI sub-study. A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing.

  • Mean Regional Wall Motion Score Index at Week 12 [ Time Frame: At Week 12 ]
    Wall motion score index is a semi-quantitative analysis of regional systolic function. Each segment is analyzed individually and scored on the basis of its motion and systolic thickening. This score is a 5-level score defines as: 1=normokinesis or hyperkinesis, 2=hypokinesi, 3=akinesis, 4=dyskinesis, 5=aneurysm. Wall motion score index is derived as a sum of all scores divided by the number of segments visualized. Larger score index indicates higher degree of abnormalities. Cardiac MRIs were performed at qualified sites on participants who agree to participate in the MRI sub-study. A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing.

  • Mean Hyperenhancement Score Index at Week 12 [ Time Frame: At week 12 ]
    The myocardium was divided into 17 segments. A score ranging from 0 to 4 was visually attributed to each of the 17 segments according to the transmural extent of the hyperenhancement: score 0=0%, 1=>0-25%, 2=>25-50%, 3=>50-75% and 4=>75-100%. All these 17 scores were summed. The resulting summed score ranged in theory from 0 to 68 and was thereafter expressed as a percentage of the maximum possible score of 68, with higher percentages indicating hyper-enhancement in a greater percentage of the tissue in a greater number of segments. Cardiac MRIs were performed at qualified sites on participants who agree to participate in the MRI sub-study. A total of 15 participants out of 93 MRI ITT participants were excluded from the analysis due to missing Baseline cTnI (10 participants) and onset chest pain duration (9 participants). Four participants had both covariate values missing. Statistical analysis was performed on LS mean value using repeated measures ANCOVA.


Enrollment: 526
Actual Study Start Date: October 8, 2009
Study Completion Date: March 6, 2012
Primary Completion Date: March 6, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A
7.5 mg GW856553 starting dose, followed 12 hours later by 7.5mg twice daily for 12 weeks
Drug: GW856553
7.5 mg GW856553 starting dose, followed 12 hours later by 7.5mg BID
Experimental: Treatment B
15 mg GW856553 starting dose, followed 12 hours later by 7.5mg twice daily for 12 weeks
Drug: GW856553
15 mg GW856553 starting dose, followed 12 hours later by 7.5mg BID
Placebo Comparator: Treatment C
Placebo twice daily for 12 weeks
Drug: Placebo
Placebo

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with a NSTEMI, defined as: symptoms (e.g. chest pain, dyspnea) consistent with acute coronary syndrome, lasting at least 10 minutes, with most recent symptoms occurring within the 24 hours prior to presentation, without persistent ST-segment elevation on admission 12-lead ECG, and with Troponin (T or I) above the upper limit of normal (ULN) for the local institution within 18 hours of presentation.
  • Subject able to be randomized within 18 hours of presentation.
  • Subjects to be managed with an early invasive strategy, with PCI likely to occur at least 2 hours after the start of dosing [subjects who do not undergo PCI will not be withdrawn from the study].
  • Male or female subject who is 45 years of age or older.
  • A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) greater than 40 MlU/ml and estradiol less than 40 pg/ml (less than 140 pmol/L) is confirmatory), or child-bearing potential and agrees to use one of the contraception methods listed in the protocol for the duration of dosing and until the first follow-up visit (approximately 2 weeks post last-dose).
  • Negative urine or serum pregnancy test (in women of child-bearing potential only).
  • Male subjects must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until the first follow-up visit (approximately 2 weeks post last-dose).
  • QTcB or QTcF greater than 530 msec.
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Exclusion Criteria:

  • History of severe heart failure defined as NYHA class III or IV or those with known severe LV dysfunction [ejection fraction less than 30%] regardless of symptomatic status.
  • Suspected aortic dissection.
  • Severe aortic stenosis or other severe valvular disease.
  • Current known life-threatening condition other than vascular disease (e.g. severe chronic airways disease) that may prevent a subject from completing the study.
  • Subjects with rheumatoid arthritis, connective tissue disorders and other conditions known to be associated with active chronic or acute inflammation (e.g. inflammatory bowel disease, osteomyelitis, pneumonia, etc.). Intermittent conditions treated with short-term oral antibiotics (e.g. typical URI) or conditions that are not currently exacerbated (e.g. gout with no current flair) may be included.
  • History of myopathy or rhabdomyolysis.
  • Current or chronic history of liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • Known to be Hepatitis B or Hepatitis C positive.
  • Current or anticipated use of systemic steroids (oral or IV). Inhaled, intranasal and topical steroids are allowed. A single prophylactic dose of systemic steroid is allowed at time of PCI for subjects with contrast allergy.
  • Current or anticipated use of BCRP substrates with a narrow therapeutic index (e.g. daunorubicin, doxorubicin, topotecan, mitoxantrone).
  • Previously diagnosed cancer that has not been in complete remission for at least 5 years. Localized carcinomas of the skin and carcinoma in situ of the cervix that have been resected or ablated for cure are not exclusionary..
  • Known alcohol or drug abuse within the past 6 months.
  • Previous exposure to GW856553.
  • Use of another investigational product within 30 days or 5 half-lives (whichever is the longer) preceding the first dose of IP in the current study.
  • Any other subject whom the Investigator deems unsuitable for the study (e.g., due to either medical reasons, laboratory abnormalities, expected study medication non-compliance).
  • Unwillingness or inability to follow the procedures outlined in the protocol.
  • Previous MI or coronary artery bypass graft (CABG) surgery.
  • History of kidney transplant or a history of contrast nephropathy.
  • Contraindication to MRI scanning (as assessed by local MRI safety questionnaire) which includes but is not limited to: intracranial aneurysm clips or other metallic objects; history of intra-orbital metal fragments that have not been removed by an MD; pacemakers and non-MR compatible heart valves; inner ear implants; history of claustrophobia in MR.
  • Allergy to MRI contrast enhancement agent (gadolinium).
  • Estimated creatinine clearance by Cockcroft-Gault formula < 30 mL/min.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00910962


  Hide Study Locations
Locations
United States, Alaska
GSK Investigational Site
Anchorage, Alaska, United States, 99508
United States, Arizona
GSK Investigational Site
Tucson, Arizona, United States, 85724
United States, California
GSK Investigational Site
Los Angeles, California, United States, 90033
GSK Investigational Site
Mission Viejo, California, United States, 92691
United States, Florida
GSK Investigational Site
Jacksonville, Florida, United States, 32209
GSK Investigational Site
Saint Petersburg, Florida, United States, 33701
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30322
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60612
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46290
United States, Iowa
GSK Investigational Site
Iowa City, Iowa, United States, 52242
United States, Kentucky
GSK Investigational Site
Lexington, Kentucky, United States, 40536-0284
United States, Minnesota
GSK Investigational Site
Minneapolis, Minnesota, United States, 55407
GSK Investigational Site
Rochester, Minnesota, United States, 55905
United States, New York
GSK Investigational Site
Brooklyn, New York, United States, 11215
GSK Investigational Site
Stony Brook, New York, United States, 11794
United States, North Carolina
GSK Investigational Site
Durham, North Carolina, United States, 27710
GSK Investigational Site
Raleigh, North Carolina, United States, 27610
United States, Ohio
GSK Investigational Site
Elyria, Ohio, United States, 44035
United States, Pennsylvania
GSK Investigational Site
Allentown, Pennsylvania, United States, 18103
GSK Investigational Site
Camp Hill, Pennsylvania, United States, 17011
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19141
United States, South Dakota
GSK Investigational Site
Rapid City, South Dakota, United States, 57701
United States, Tennessee
GSK Investigational Site
Knoxville, Tennessee, United States, 37917
GSK Investigational Site
Oak Ridge, Tennessee, United States, 37830
United States, Texas
GSK Investigational Site
Amarillo, Texas, United States, 79106
GSK Investigational Site
Austin, Texas, United States, 78756
GSK Investigational Site
Dallas, Texas, United States, 75216
GSK Investigational Site
Fort Worth, Texas, United States, 76104
GSK Investigational Site
Round Rock, Texas, United States, 78681
GSK Investigational Site
Victoria, Texas, United States, 77901
Australia, New South Wales
GSK Investigational Site
Kogarah, New South Wales, Australia, 2217
GSK Investigational Site
Liverpool, New South Wales, Australia, 2170
Australia, Queensland
GSK Investigational Site
Brisbane, Queensland, Australia, 4032
Australia, South Australia
GSK Investigational Site
Bedford Park, South Australia, Australia, 5042
GSK Investigational Site
Woodville South, South Australia, Australia, 5011
Australia, Tasmania
GSK Investigational Site
Launceston, Tasmania, Australia, 7250
Australia, Western Australia
GSK Investigational Site
Fremantle, Western Australia, Australia, 6160
GSK Investigational Site
Perth, Western Australia, Australia, 6000
Canada, Alberta
GSK Investigational Site
Calgary, Alberta, Canada, T2N 2T9
Canada, Quebec
GSK Investigational Site
Montreal, Quebec, Canada, H1T 1C8
GSK Investigational Site
Sainte-Foy, Quebec, Canada, G1V 4G5
GSK Investigational Site
Terrebonne, Quebec, Canada, J6V 2H2
Germany
GSK Investigational Site
Bad Krozingen, Baden-Wuerttemberg, Germany, 79189
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68167
GSK Investigational Site
Rastatt, Baden-Wuerttemberg, Germany, 76437
GSK Investigational Site
Ulm, Baden-Wuerttemberg, Germany, 89081
GSK Investigational Site
Potsdam, Brandenburg, Germany, 14467
GSK Investigational Site
Bad Nauheim, Hessen, Germany, 61231
GSK Investigational Site
Darmstadt, Hessen, Germany, 64283
GSK Investigational Site
Frankfurt, Hessen, Germany, 60590
GSK Investigational Site
Fulda, Hessen, Germany, 36043
GSK Investigational Site
Limburg, Hessen, Germany, 65549
GSK Investigational Site
Goettingen, Niedersachsen, Germany, 37075
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
GSK Investigational Site
Oldenburg, Niedersachsen, Germany, 26133
GSK Investigational Site
Aachen, Nordrhein-Westfalen, Germany, 52074
GSK Investigational Site
Bielefeld, Nordrhein-Westfalen, Germany, 33604
GSK Investigational Site
Bonn, Nordrhein-Westfalen, Germany, 53127
GSK Investigational Site
Dortmund, Nordrhein-Westfalen, Germany, 44137
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45138
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51109
GSK Investigational Site
Leverkusen, Nordrhein-Westfalen, Germany, 51375
GSK Investigational Site
Neuss, Nordrhein-Westfalen, Germany, 41464
GSK Investigational Site
Wuppertal, Nordrhein-Westfalen, Germany, 42117
GSK Investigational Site
Worms, Rheinland-Pfalz, Germany, 67550
GSK Investigational Site
Halle, Sachsen-Anhalt, Germany, 06120
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39120
GSK Investigational Site
Dresden, Sachsen, Germany, 01307
GSK Investigational Site
Leipzig, Sachsen, Germany, 04289
GSK Investigational Site
Pirna, Sachsen, Germany, 01796
GSK Investigational Site
Bad Berka, Thueringen, Germany, 99437
GSK Investigational Site
Erfurt, Thueringen, Germany, 99089
GSK Investigational Site
Berlin, Germany, 10117
GSK Investigational Site
Berlin, Germany, 10249
GSK Investigational Site
Berlin, Germany, 13353
GSK Investigational Site
Berlin, Germany, 13509
GSK Investigational Site
Berlin, Germany, 14165
GSK Investigational Site
Hamburg, Germany, 20099
GSK Investigational Site
Hamburg, Germany, 22291
India
GSK Investigational Site
Ahmedabad, India, 380060
GSK Investigational Site
Bangalore, India, 560052
GSK Investigational Site
Bangalore, India, 560054
GSK Investigational Site
Bangalore, India, 560099
GSK Investigational Site
Calicut, India, 673002
GSK Investigational Site
Pune, India, 411004
Netherlands
GSK Investigational Site
Amsterdam, Netherlands, 1091 AC
GSK Investigational Site
Amsterdam, Netherlands, 1105 AZ
GSK Investigational Site
Arnhem, Netherlands, 6815 AD
GSK Investigational Site
Nieuwegein, Netherlands, 3435 CM
GSK Investigational Site
Tilburg, Netherlands, 5022 GC
Poland
GSK Investigational Site
Krakow, Poland, 30-901
GSK Investigational Site
Krakow, Poland, 31-501
GSK Investigational Site
Krakow, Poland
GSK Investigational Site
Radom, Poland, 26-617
GSK Investigational Site
Warszawa, Poland, 04-628
Spain
GSK Investigational Site
Alicante, Spain, 03010
GSK Investigational Site
Barcelona, Spain, 08907
GSK Investigational Site
Jerez (Cadiz), Spain, 11047
GSK Investigational Site
Málaga, Spain, 29010
GSK Investigational Site
Santiago de Compostela, Spain, 15706
United Kingdom
GSK Investigational Site
Brighton, East Sussex, United Kingdom, BN2 5BE
GSK Investigational Site
Bristol, United Kingdom, BS2 8HW
GSK Investigational Site
Clydebank, United Kingdom, G81 4HX
GSK Investigational Site
Edinburgh, United Kingdom, EH16 4SA
GSK Investigational Site
Leicester, United Kingdom, LE3 9QP
GSK Investigational Site
London, United Kingdom, SE1 7EH
GSK Investigational Site
London, United Kingdom, SE5 9RS
GSK Investigational Site
Paddington, London, United Kingdom, W2 1NY
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 111810
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 111810
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 111810
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 111810
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 111810
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 111810
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 111810
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00910962     History of Changes
Other Study ID Numbers: 111810
First Submitted: May 28, 2009
First Posted: June 1, 2009
Results First Submitted: August 18, 2017
Results First Posted: October 27, 2017
Last Update Posted: December 7, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
URL: http://

Keywords provided by GlaxoSmithKline:
NSTEMI, acute coronary syndrome, p38 MAPK inhibitor, GW856553, percutaneous coronary intervention

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases