NCT00327041

Brief Summary

Antiplatelet therapy plays a key role in the prevention of complications related to coronary angioplasty and stenting (PCI) including procedure related myocardial damage. Aspirin and clopidogrel are now universally prescribed in patients undergoing these procedures. However, loading and maintenance doses have not been established and variation in individual response is emerging. New tests to assess the effects of these drugs are being developed but have yet to be incorporated into routine clinical practice. We will assess the effects of aspirin and clopidogrel in a consecutive series of patients undergoing angioplasty using new assays which can be carried out at the bedside. We will compare the results with alternative laboratory based tests and look for an association between the results, peri-procedural myocardial necrosis and subsequent cardiovascular events.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

May 17, 2006

Status Verified

May 1, 2006

First QC Date

May 15, 2006

Last Update Submit

May 15, 2006

Conditions

Coronary StenosisCoronary ThrombosisAngioplasty, Balloon

Keywords

AspirinClopidogrelBalloon AngioplastyCoronary Thrombosis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18-80 undergoing intended PCI for conventional indications. Informed written consent.

You may not qualify if:

  • Administration of GPIIbIIIa therapy prior to PCI, Oral anticoagulation, ticlopidine, dipyridamole, NSAID therapy, Pregnancy, Troponin I \>0.2mcg/l on day of procedure, Chest pain in the 24 hrs prior to PCI. Anaemia (Hb\<10g/dl). Platelet Count \<150 or \>450 x10\^9/l, Personal or family history of bleeding disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Infirmary

Glasgow, Scotland, G11 6NT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Coronary StenosisCoronary Thrombosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesThrombosisEmbolism and Thrombosis

Study Officials

  • Keith G Oldroyd, MBChB, MD, FRCP

    NHS Greater Glasgow and Clyde

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard IS Good, BA MBBS MRCP

CONTACT

0044 141 211 6390richard_good@hotmail.com

Keith G Oldroyd, MBChB, MD, FRCP

CONTACT

0044 141 211 2337keith.Oldroyd@northglasgow.scot.nhs.uk

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 15, 2006

First Posted

May 17, 2006

Study Start

January 1, 2006

Study Completion

September 1, 2006

Last Updated

May 17, 2006

Record last verified: 2006-05

Locations

GB(1)