Clinical trial NCT00728286: Assessment of Thrombogenicity in Acute Coronary Syndrome
Official title: Assessment of Platelet-dependent Thrombosis in Patients With Acute Coronary Syndromes Using an ex Vivo Arterial Injury Model
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Acute Coronary Syndrome
Keywords: Type 2 Diabetes Mellitus
Acute Coronary Syndrome
Platelet dependent thrombogenicity
Lead sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
name: University of Newcastle Upon-Tyne
First posted: 2008-08-05
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with non-ST elevation myocardial infarction - Acute Coronary syndrome (ACS) and on existing medication will undergo chamber study

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Thrombus area
timeFrame: Within 10 days after acute coronary syndrome
Secondary outcomes:
measure: Factors affecting thrombus area
timeFrame: Within ten days after acute coronary syndrome
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Royal Victoria Hospital, Newcastle upon Tyne Hospitals NHS Trust
state: Tyne and Wear
Study officials:
affiliation: Freeman Hospital, Newcastle upon Tyne NHS Trust, Newcastle upon Tyne. NE7 7DN
name: Azfar G Zaman, MD FRCP
role: PRINCIPAL_INVESTIGATOR
References:
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. No abstract available.
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. doi: 10.1016/s0735-1097(01)01555-8.
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. doi: 10.1016/s0735-1097(99)00545-8.
citation: 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. doi: 10.1161/01.atv.20.10.2316.