The effects of tumour necrosis factor antagonism (Etanercept) in patients with acute coronary syndromes

Phase 2

Completed

• Conditions: Acute myocardial infarction; Circulatory System; Acute myocardial infarction, unspecified

• Registration Number: ISRCTN97018444
• Lead Sponsor: niversity of Edinburgh (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-14
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

1. A typical history of myocardial ischaemia lasting more than 20 minutes within 24 hours prior to admission
2. An elevated troponin I(>0.1µg/L) and/or electrocardiographic changes
3. Age =18 years of age, either sex
4. Screening full blood count (FBC) must meet the following criteria: healmoglobin (Hb) > 85g/L, white cell count (WCC) > 3.5 x 109/L, neutrophils > 1.5 x 109/L, platelets > 100 x 109/L
5. Subjects must be able to adhere to the study visit schedule and other protocol requirements
6. The subject must be capable of giving informed consent and the consent must be obtained prior to screening procedures

Exclusion Criteria

1. Women of child bearing potential
2. Systolic blood pressure >190mmHg or <100mmHg
3. Malignant arrhythmias
4. Renal or hepatic failure
5. Severe or significant co-morbidity
6. Previous history of blood dyscrasia
7. Unable to tolerate the supine position
8. Opportunistic infection within the previous 6 months, human immunodeficiency virus, serious infection within the previous 2 months, chronic/recurrent infection
9. A history of malignancy within the previous 5 years, lymphoproliferative disease, or multiple sclerosis/ other demyelinating disorder
10. Patients with diabetes mellitus (type 1 or insulin-dependent)
11. Patients with systemic inflammatory disorder
12. Use of any investigational drug within 1 month prior to screening or within five half-lives of investigational agent, whichever is longer
13. Treatment with any other therapeutic agent targeted at reducing TNF (e...g pentoxifylline, thalidomide, etanercept etc) within 3 months of screening
14. Known recent substance abuse (drugs or alcohol)
15. Poor tolerability of venepuncture or lack of adequate venous access for required blood sampling during the study period

Study & Design

• Study Type: Interventional
• Study Design: Not specified