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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00910962




Registration number
NCT00910962
Ethics application status
Date submitted
28/05/2009
Date registered
1/06/2009

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
111810
Universal Trial Number (UTN)
Trial acronym
Solstice
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GW856553
Treatment: Drugs - GW856553
Treatment: Drugs - Placebo

Experimental: Treatment A - 7.5 mg GW856553 starting dose, followed 12 hours later by 7.5mg twice daily for 12 weeks

Experimental: Treatment B - 15 mg GW856553 starting dose, followed 12 hours later by 7.5mg twice daily for 12 weeks

Placebo comparator: Treatment C - Placebo twice daily for 12 weeks


Treatment: Drugs: GW856553
7.5 mg GW856553 starting dose, followed 12 hours later by 7.5mg BID

Treatment: Drugs: GW856553
15 mg GW856553 starting dose, followed 12 hours later by 7.5mg BID

Treatment: Drugs: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Up to Week 14
Primary outcome [2] 0 0
Number of Participants With Any Major Adverse Cardiovascular Events (MACE)
Timepoint [2] 0 0
Up to Week 14
Primary outcome [3] 0 0
Number of Participants With Any Pure MACE
Timepoint [3] 0 0
Up to Week 14
Primary outcome [4] 0 0
Number of Participants With Hematology Data of Potential Clinical Importance (PCI) at Any Visit Post-Baseline
Timepoint [4] 0 0
Up to Week 14
Primary outcome [5] 0 0
Number of Participants With Clinical Chemistry Data of PCI at Any Visit Post-Baseline
Timepoint [5] 0 0
Up to Week 14
Primary outcome [6] 0 0
Number of Participants With Liver Function Test Elevations at Any Time Post-Baseline
Timepoint [6] 0 0
Up to Week 14
Primary outcome [7] 0 0
Number of Participants With Abnormal Electrocardiogram (ECG) Findings at Any Time Post-Baseline
Timepoint [7] 0 0
Up to Week 14
Primary outcome [8] 0 0
Number of Participants With Vital Signs of PCI at Any Visit Post-Baseline
Timepoint [8] 0 0
Up to Week 14
Primary outcome [9] 0 0
Mean High-sensitive C-Reactive Protein (hsCRP) Value at Week 12
Timepoint [9] 0 0
At Week 12
Primary outcome [10] 0 0
Mean Cardiac Troponin I (cTnI) Area Under Concentration-time Curve (AUC) Over 72 Hours Post-randomization or Until Hospital Discharge (Whichever Comes First)
Timepoint [10] 0 0
At pre-dose and at 8, 16, 24, 32, 40, 48, 56, 64 and 72 hours
Secondary outcome [1] 0 0
Mean hsCRP Over Hospitalization Period and Through Week 14
Timepoint [1] 0 0
Up to Week 14
Secondary outcome [2] 0 0
Mean Interleukin-6 (IL-6) Value at 24 Hours Post-randomization and at Weeks 2 and 12
Timepoint [2] 0 0
24 hours post-randomization and at Weeks 2 and 12
Secondary outcome [3] 0 0
Mean Creatine Kinase (MB Isoenzyme) (CK-MB) AUC Over 72 Hours Post-randomization or Until Hospital Discharge (Whichever Comes First)
Timepoint [3] 0 0
At pre-dose and at hours 8, 16, 24, 32, 40, 48, 56, 64 and 72
Secondary outcome [4] 0 0
Peak cTnI Over 72 Hours Post-randomization or Until Hospital Discharge (Whichever Comes First)
Timepoint [4] 0 0
Up to 72 hours
Secondary outcome [5] 0 0
Mean Brain Natriuretic Peptide (BNP) at Discharge and Week 12
Timepoint [5] 0 0
At discharge and Week 12
Secondary outcome [6] 0 0
Mean Infarct Size Prior to Discharge From Hospital (Approximately Day 3) and at Week 12
Timepoint [6] 0 0
Prior to discharge (visit 1) and at Week 12
Secondary outcome [7] 0 0
Mean Percent Left Ventricular Ejection Fraction (LVEF) at Week 12
Timepoint [7] 0 0
At Week 12
Secondary outcome [8] 0 0
Mean Left Ventricular End-diastolic Volume (LVEDV) and Left Ventricular End-systolic Volume (LVESV) at Week 12
Timepoint [8] 0 0
At Week 12
Secondary outcome [9] 0 0
Mean Left Ventricular Mass at Week 12
Timepoint [9] 0 0
At Week 12
Secondary outcome [10] 0 0
Mean Regional Wall Motion Score Index at Week 12
Timepoint [10] 0 0
At Week 12
Secondary outcome [11] 0 0
Mean Hyperenhancement Score Index at Week 12
Timepoint [11] 0 0
At week 12

Eligibility
Key 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.
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/10/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/03/2012
Sample size
Target
Accrual to date
Final
526
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Kogarah
Recruitment hospital [2] 0 0
GSK Investigational Site - Liverpool
Recruitment hospital [3] 0 0
GSK Investigational Site - Brisbane
Recruitment hospital [4] 0 0
GSK Investigational Site - Bedford Park
Recruitment hospital [5] 0 0
GSK Investigational Site - Woodville South
Recruitment hospital [6] 0 0
GSK Investigational Site - Launceston
Recruitment hospital [7] 0 0
GSK Investigational Site - Fremantle
Recruitment hospital [8] 0 0
GSK Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
4032 - Brisbane
Recruitment postcode(s) [4] 0 0
5042 - Bedford Park
Recruitment postcode(s) [5] 0 0
5011 - Woodville South
Recruitment postcode(s) [6] 0 0
7250 - Launceston
Recruitment postcode(s) [7] 0 0
6160 - Fremantle
Recruitment postcode(s) [8] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alaska
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Minnesota
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
South Dakota
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
Canada
State/province [18] 0 0
Alberta
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
Germany
State/province [20] 0 0
Baden-Wuerttemberg
Country [21] 0 0
Germany
State/province [21] 0 0
Brandenburg
Country [22] 0 0
Germany
State/province [22] 0 0
Hessen
Country [23] 0 0
Germany
State/province [23] 0 0
Niedersachsen
Country [24] 0 0
Germany
State/province [24] 0 0
Nordrhein-Westfalen
Country [25] 0 0
Germany
State/province [25] 0 0
Rheinland-Pfalz
Country [26] 0 0
Germany
State/province [26] 0 0
Sachsen-Anhalt
Country [27] 0 0
Germany
State/province [27] 0 0
Sachsen
Country [28] 0 0
Germany
State/province [28] 0 0
Thueringen
Country [29] 0 0
Germany
State/province [29] 0 0
Berlin
Country [30] 0 0
Germany
State/province [30] 0 0
Hamburg
Country [31] 0 0
India
State/province [31] 0 0
Ahmedabad
Country [32] 0 0
India
State/province [32] 0 0
Bangalore
Country [33] 0 0
India
State/province [33] 0 0
Calicut
Country [34] 0 0
India
State/province [34] 0 0
Pune
Country [35] 0 0
Netherlands
State/province [35] 0 0
Amsterdam
Country [36] 0 0
Netherlands
State/province [36] 0 0
Arnhem
Country [37] 0 0
Netherlands
State/province [37] 0 0
Nieuwegein
Country [38] 0 0
Netherlands
State/province [38] 0 0
Tilburg
Country [39] 0 0
Poland
State/province [39] 0 0
Krakow
Country [40] 0 0
Poland
State/province [40] 0 0
Radom
Country [41] 0 0
Poland
State/province [41] 0 0
Warszawa
Country [42] 0 0
Spain
State/province [42] 0 0
Alicante
Country [43] 0 0
Spain
State/province [43] 0 0
Barcelona
Country [44] 0 0
Spain
State/province [44] 0 0
Jerez (Cadiz)
Country [45] 0 0
Spain
State/province [45] 0 0
Málaga
Country [46] 0 0
Spain
State/province [46] 0 0
Santiago de Compostela
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Brighton, East Sussex
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Bristol
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Clydebank
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Edinburgh
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Leicester
Country [52] 0 0
United Kingdom
State/province [52] 0 0
London
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Paddington, London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT00910962