NCT00728286

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

October 12, 2015

Status Verified

October 1, 2015

Enrollment Period

2.3 years

First QC Date

August 1, 2008

Last Update Submit

October 7, 2015

Conditions

Type 2 Diabetes MellitusAcute Coronary Syndrome

Keywords

Type 2 Diabetes MellitusAcute Coronary SyndromePlatelet dependent thrombogenicity

Outcome Measures

Primary Outcomes (1)

  • Thrombus area

    Within 10 days after acute coronary syndrome

Secondary Outcomes (1)

  • Factors affecting thrombus area

    Within ten days after acute coronary syndrome

Study Arms (1)

Type 2 diabetes mellitus

We aim to determine the effects of dual antiplatelet therapy with aspirin 75mg once a day and clopidogrel 75mg once a day on platelet dependent thrombogenicity in patients with type 2 diabetes mellitus and acute coronary syndrome. Eighty patients (40 with type 2 diabetes and 40 without) have been studied one week after Non ST-elevation acute coronary syndrome. All patients were on secondary prevention therapy as recommended by international guidelines.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with non-ST elevation myocardial infarction - Acute Coronary syndrome (ACS) and on existing medication will undergo chamber study

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Victoria Hospital, Newcastle upon Tyne Hospitals NHS Trust

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

Location

Related Publications (4)

  • 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.

    PMID: 18983525BACKGROUND

  • 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.

    PMID: 11691500BACKGROUND

  • 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.

    PMID: 10676673BACKGROUND

  • 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.

    PMID: 11031221BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Azfar G Zaman, MD FRCP

    Freeman Hospital, Newcastle upon Tyne NHS Trust, Newcastle upon Tyne. NE7 7DN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2008

First Posted

August 5, 2008

Study Start

October 1, 2008

Primary Completion

January 1, 2011

Study Completion

May 1, 2011

Last Updated

October 12, 2015

Record last verified: 2015-10

Locations

GB(1)