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Assessment of Thrombotic Status in Patients With Acute Coronary Syndrome

Assessment of Thrombotic Status in Patients With Acute Coronary Syndrome

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02562690
Enrollment
500
Registered
2015-09-29
Start date
2015-03-31
Completion date
2020-02-29
Last updated
2016-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Keywords

Coronary Artery Disease, Myocardial Ischemia, Arterial Occlusive Diseases, Coronary Thrombosis

Brief summary

Impaired thrombotic status is associated with adverse cardiovascular events. Patients with acute coronary syndrome (ACS) are at increased cardiovascular risk. The aim of the study is to determine the usefulness of thrombotic status assessment in a large cohort of ACS patients, managed with contemporary treatments, to identify patients at risk of thrombosis and those at risk of bleeding complications.

Detailed description

Patients presenting with acute coronary syndrome (ACS) are at increased risk of future cardiovascular events, despite optimal medical treatment and coronary intervention. Such events are usually caused by increased stickiness of the blood causing a blood clot (thrombus) to block arterial blood vessels in the heart. Much of the medication to prevent recurrent thrombotic events increases the risk of bleeding complications. Identification of patients at recurrent thrombotic risk could allow targeted treatment with potent antithrombotic medications, with less potent agents in others to reduce bleeding. The investigators will assess the stickiness of the blood (i.e. thrombotic status) in patients who are admitted to hospital with ACS; at baseline, at discharge from hospital and at 30 days post hospitalisation. Blood stickiness will be tested using a number of tests of thrombotic status including thrombin generation assays, Thromboelastography (TEG) and the near-patient, point-of-care Global Thrombosis Test (GTT). The results will be evaluated to assess the effect of disease process and clinical state on blood stickiness to gain further understanding of the condition and form the basis for future studies aimed at identifying patients who are at high risk of future cardiovascular events.

Interventions

OTHERThrombin generation assays, TEG and GTT

Thrombin generation assays, Thromboelastography (TEG), and Global Thrombosis Test (GTT)

Sponsors

East and North Hertfordshire NHS Trust
CollaboratorOTHER_GOV
University of Hertfordshire
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Male and female patients aged 18 years or over. 2. Patients diagnosed with ACS and free of

Exclusion criteria

below. 3. The patient is willing and able to understand the Patient Information Sheet and provide written informed consent. 4. The patient must agree to comply with the drawing of blood samples for the assessments.

Design outcomes

Primary

MeasureTime frame
Co-primary endpoints of Major Adverse Cardiovascular Events (MACE) and major bleeding12 months

Secondary

MeasureTime frame
Target Lesion Revascularization12 months

Countries

United Kingdom

Contacts

Primary ContactDr. Mohamed Farag, MSc
mohamedfarag@nhs.net
Backup ContactProf. Diana A Gorog, MD, PhD
d.gorog@imperial.ac.uk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026