- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02562690
Assessment of Thrombotic Status in Patients With Acute Coronary Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Dr. Mohamed Farag, MSc
- Email: mohamedfarag@nhs.net
Study Contact Backup
- Name: Prof. Diana A Gorog, MD, PhD
- Email: d.gorog@imperial.ac.uk
Study Locations
-
-
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Hertfordshire, United Kingdom, SG1 4AB
- Recruiting
- Hertfordshire Cardiology Centre, East and North Hertfordshire NHS Trust
-
Contact:
- Rishma Bhatti
- Email: rbhatti@nhs.net
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Principal Investigator:
- Prof. Diana A Gorog, MD, PhD
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Sub-Investigator:
- Dr. Mohamed Farag, MSc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male and female patients aged 18 years or over.
- Patients diagnosed with ACS and free of exclusion criteria below.
- The patient is willing and able to understand the Patient Information Sheet and provide written informed consent.
- The patient must agree to comply with the drawing of blood samples for the assessments.
Exclusion Criteria:
- The patient has, in the opinion of the investigator, significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, haemorrhagic, metabolic or other disease likely to confound the study requirements or analyses.
- The patient has a history of substance abuse or demonstrates signs or clinical features of active substance abuse or psychiatric disease.
- Alcohol consumption above recommended safe levels (i.e. more than 21 units per week for males, or more than 14 units per week for females) due to the potential effects of high alcohol levels on platelet reactivity.
- Any illness deemed significant by the investigator during the four (4) weeks preceding the screening period of the study.
- Any major bleeding diathesis or blood dyscrasia (platelets < 70 x 109/l, Hb < 8 g/dl, INR > 1.4, APTT > x 2 UNL, leucocyte count < 3.5 x 109/l, neutrophil count < 1 x 109/l).
- Currently enrolled in an investigational device or drug trial.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Acute Coronary Syndrome
Patients with acute chest pain and persistent ST-segment elevation or new left bundle branch block on the 12 lead ECG. This is termed ST-segment Elevation Myocardial Infarction (STEMI). Patients with acute chest pain but without persistent ST-segment elevation. These patients, based on the measurement of cardiac biomarker values (troponin), will be further classified as Non-ST-segment Elevation Myocardial Infarction (NSTEMI) or unstable angina. Where possible, all patients will have tests of thrombotic status including thrombin generation assays, TEG and GTT. |
Thrombin generation assays, Thromboelastography (TEG), and Global Thrombosis Test (GTT)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Co-primary endpoints of Major Adverse Cardiovascular Events (MACE) and major bleeding
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Target Lesion Revascularization
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Prof. Diana A Gorog, MD, PhD, East and North Hertfordshire NHS Trust
Publications and helpful links
General Publications
- Farag M, Spinthakis N, Gue YX, Srinivasan M, Sullivan K, Wellsted D, Gorog DA. Impaired endogenous fibrinolysis in ST-segment elevation myocardial infarction patients undergoing primary percutaneous coronary intervention is a predictor of recurrent cardiovascular events: the RISK PPCI study. Eur Heart J. 2019 Jan 14;40(3):295-305. doi: 10.1093/eurheartj/ehy656.
- Farag M, Spinthakis N, Srinivasan M, Sullivan K, Wellsted D, Gorog DA. Morphine Analgesia Pre-PPCI Is Associated with Prothrombotic State, Reduced Spontaneous Reperfusion and Greater Infarct Size. Thromb Haemost. 2018 Mar;118(3):601-612. doi: 10.1055/s-0038-1629896. Epub 2018 Feb 14.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RD2014-134
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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