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OpenTrials
Completed

NCT Number: NCT00728286

Assessment of Thrombogenicity in Acute Coronary Syndrome

The purpose of this study is to assess platelet dependent thrombogenicity in patients after acute coronary syndrome using an ex vivo arterial injury model.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Victoria Hospital, Newcastle upon Tyne Hospitals NHS Trust

Newcastle upon Tyne, Tyne and Wear, NE1 4LP, United Kingdom

About this study

Abnormal platelet activity seen in patients with Type2 Diabetes Mellitus (T2DM) may be an important contributor to their enhanced cardiovascular risk and higher rates of cardiovascular events following acute coronary syndrome, despite dual antiplatelet therapy with aspirin and clopidogrel. We have earlier demonstrated high thrombogenicity in individuals with T2DM and CAD in the absence of acute ischaemic events, despite therapeutic doses of aspirin.We hypothesise that patients with T2DM will have increased thrombogenicity after acute coronary syndrome despite optimal secondary prevention medication.Measuring ex vivo thrombus area using an arterial injury model simulates plaque rupture and reflects the summative effect of all haemostatic abnormalities. The thrombus area of patients with ACS and T2DM will be compared to the controls without T2DM.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute coronary syndrome (WHO criteria) with raised cardiac troponin T
  • Aged 18-80 years
  • Stable Acute coronary syndrome
  • On aspirin and clopidogrel
  • Willing to participate in the study

Exclusion criteria

  • Smoking (current smokers or smokers who quit in the last 6 months preceding recruitment)
  • Malignancy (any suspected or proven)
  • Haematological disorders (bleeding disorders)
  • Pre-menopausal women
  • Use of corticosteroids/other antithrombotic agents (warfarin)
  • Chronic liver disease
  • Unable to consent

Treatment and study plan

Primary outcomes

  1. Thrombus area

    Time frame: Within 10 days after acute coronary syndrome

Secondary outcomes

  1. Factors affecting thrombus area

    Time frame: Within ten days after acute coronary syndrome

Sponsors and collaborators

Lead sponsor

Newcastle-upon-Tyne Hospitals NHS Trust

Other

Collaborators

  • British Heart Foundation
  • University of Newcastle Upon-Tyne

Registry information

Official study title

Assessment of Platelet-dependent Thrombosis in Patients With Acute Coronary Syndromes Using an ex Vivo Arterial Injury Model

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Aug 5, 2008
Registry last updated
Oct 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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