Prolonged Enoxaparin In Primary Percutaneous Coronary Intervention; A Pilot Pharmacodynamic Study

NCT03146858 | Completed Phase 4 DMC

• 1 other identifier: STH19752
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Heart attacks are caused by a clot blocking one or more of the heart arteries (coronary arteries). When complete blockage of one of the arteries occurs, emergency treatment to unblock the affected artery and rescue the heart muscle at risk is essential. This is usually achieved by performing an emergency procedure called primary percutaneous coronary intervention (PPCI). Anticlotting treatment is also necessary to reduce the chances of further heart attacks. As part of standard care, tablets that target small cells called platelets (central to blood clot formation) are given as soon as an acute heart attack is suspected. These tablets include aspirin and ticagrelor/prasufrel. Although both ticgrelor and prasugrel are effective, the onset of action is delayed by up to 8 hours when given in context of an acute heart attack. This delay in onset of action can increase the risk of further heart attacks. Enoxaparin is an anticlotting treatment that targets the other aspect of clot formation known as coagulation cascade. Enoxaparin or an alternative is recommended as a single does to support the PPCI procedure. The effects of a single shot of enoxaparin do not last long enough to bridge the gap in anticlotting treatment caused by the delayed action of ticagrelor/prasugrel. Since the investigators have realised the delayed onset of action of tablet therapy, the investigators have been using another drug called tirofiban as a drip. Tirofiban blocks platelets effectively, but greatly increases the risk of bleeding events. The investigators believe that giving enoxaparin as a drip for 3-6 hours (following the single dose) instead of tirofiban, would be sufficient to bridge the gap in anticlotting effect without greatly increasing the risk of bleeding. This is a pilot study to assess the effects of enoxaparin drip in patients presenting with acute heart attacks and undergoing emergency treatment with PPCI.

Conditions

Primary Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• anti Xa activity change

  To assess the pharmacodynamic effect of a prolonged enoxaparin infusion in the context.of PPCI. This will be achieved by serial measurements of anti Xa activity.

  recruitment, baseline, 3 hrs from baseline, 6 hrs from baseline

Secondary Outcomes (3)

• P2Y12 Inhibition change

  recruitment, baseline, 3 hrs from baseline, 6 hrs from baseline

• Fibrin Clot Formation change

  recruitment, baseline, 3 hrs from baseline, 6 hrs from baseline

• Enoxaparin Regimen

  within 12 hours from baseline

Study Arms (1)

Enoxaparin

EXPERIMENTAL

The patients will receive a 3-6 hour infusion of enoxaparin. The effects of the infusion will be assess when used on patients will acute heart attacks and undergoing emergency treatment with PPCI.

Drug: Enoxaparin

Interventions

Enoxaparin DRUG

Enoxaparin is an anticlotting treatment that targets the other aspect of clot formation known as the coagulation cascade. Enoxaparin or an alternative is recommended as a single does to support PPCI procedure.

Enoxaparin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• Confirmation of the diagnosis of STEMI by the clinical team on the basis of history, ECG changes and angiographic findings
• Pre-treatment with either ticagrelor or prasugrel
• Intention to proceed with PPCI
• Feasibility to obtain informed verbal consent pre PPCI

You may not qualify if:

• Active bleeding that cannot be controlled by local measures
• Female patients of child bearing age who have not had a sterilisation procedure
• Patients with end stage renal failure requiring renal replacement therapy
• Known thrombocytopenia (Platelet count \< 100,000/μL)
• Known history of intracranial haemorrhage
• Known current treatment with oral anticoagulants
• Known history of major surgery or trauma or history of GI/GU haemorrhage within the last month
• Known intracranial malignancy or aneurysm
• Known allergy to enoxaparin
• Inability to easily understand verbal information given in English for any reason
• Inability to give informed consent due to either temporary or permanent mental incapacity

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S5 7AU, United Kingdom

Location

Related Publications (3)

• Karunakaran A, Sumaya W, Gunn JP, Morton AC, Storey RF. Contemporary management of ST-segment elevation myocardial infarction. Hosp Pract (1995). 2012 Feb;40(1):224-31. doi: 10.3810/hp.2012.02.963.

  PMID: 22406898 RESULT

• Huynh T, Perron S, O'Loughlin J, Joseph L, Labrecque M, Tu JV, Theroux P. Comparison of primary percutaneous coronary intervention and fibrinolytic therapy in ST-segment-elevation myocardial infarction: bayesian hierarchical meta-analyses of randomized controlled trials and observational studies. Circulation. 2009 Jun 23;119(24):3101-9. doi: 10.1161/CIRCULATIONAHA.108.793745. Epub 2009 Jun 8.

  PMID: 19506117 RESULT

• Task Force on the management of ST-segment elevation acute myocardial infarction of the European Society of Cardiology (ESC); Steg PG, James SK, Atar D, Badano LP, Blomstrom-Lundqvist C, Borger MA, Di Mario C, Dickstein K, Ducrocq G, Fernandez-Aviles F, Gershlick AH, Giannuzzi P, Halvorsen S, Huber K, Juni P, Kastrati A, Knuuti J, Lenzen MJ, Mahaffey KW, Valgimigli M, van 't Hof A, Widimsky P, Zahger D. ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J. 2012 Oct;33(20):2569-619. doi: 10.1093/eurheartj/ehs215. Epub 2012 Aug 24. No abstract available.

  PMID: 22922416 RESULT

MeSH Terms

Interventions

Enoxaparin

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Once patients have been recruited into the trail, they will undertake the first of 4 blood samples. Following the samples the PPCI treatment with begin. The enoxaparin infusion will be set up when the treatment begins. At the end of the PPCI treatment the second blood sample will obtained. The enoxaparin infusion will be commenced after a kidney function check has been performed. The third blood sample will be taken 3 hours into the infusion, and the 4th sample taken at the end of the 6 hour infusion. A 12 hour clinical follow up will then be performed and will mark study completion for the patient.

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: May 10, 2017
• Study Start: August 25, 2017
• Primary Completion: December 30, 2017
• Study Completion: March 30, 2018
• Last Updated: April 19, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)