Assessment of Thrombogenicity in Acute Coronary Syndrome

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00728286
• Other study ID #: 3639b
• Secondary ID: British Heart Fo
• Status: Completed
• Phase: N/A
• First received: August 1, 2008
• Last updated: October 7, 2015
• Start date: October 2008
• Est. completion date: May 2011

Study information

• Verified date: October 2015
• Source: Newcastle-upon-Tyne Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Syndrome
• Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
United Kingdom	Royal Victoria Hospital, Newcastle upon Tyne Hospitals NHS Trust	Newcastle upon Tyne	Tyne and Wear

Sponsors (3)

Lead Sponsor	Collaborator
Newcastle-upon-Tyne Hospitals NHS Trust	British Heart Foundation, University of Newcastle Upon-Tyne

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

Helft G, Osende JI, Worthley SG, Zaman AG, Rodriguez OJ, Lev EI, Farkouh ME, Fuster V, Badimon JJ, Chesebro JH. Acute antithrombotic effect of a front-loaded regimen of clopidogrel in patients with atherosclerosis on aspirin. Arterioscler Thromb Vasc Biol. 2000 Oct;20(10):2316-21. — View Citation

Natarajan A, Marshall SM, Worthley SG, Badimon JJ, Zaman AG. The presence of coronary artery disease increases platelet-dependent thrombosis in patients with type 2 diabetes mellitus. J Thromb Haemost. 2008 Dec;6(12):2210-3. doi: 10.1111/j.1538-7836.2008.03176.x. Epub 2008 Oct 1. — View Citation

Osende JI, Badimon JJ, Fuster V, Herson P, Rabito P, Vidhun R, Zaman A, Rodriguez OJ, Lev EI, Rauch U, Heflt G, Fallon JT, Crandall JP. Blood thrombogenicity in type 2 diabetes mellitus patients is associated with glycemic control. J Am Coll Cardiol. 2001 Nov 1;38(5):1307-12. — View Citation

Shechter M, Merz CN, Paul-Labrador MJ, Kaul S. Blood glucose and platelet-dependent thrombosis in patients with coronary artery disease. J Am Coll Cardiol. 2000 Feb;35(2):300-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thrombus area		Within 10 days after acute coronary syndrome	No
Secondary	Factors affecting thrombus area		Within ten days after acute coronary syndrome	No