Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prolonged Enoxaparin In Primary Percutaneous Coronary Intervention; A Pilot Pharmacodynamic Study (PENNY PCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03146858
Recruitment Status : Completed
First Posted : May 10, 2017
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

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.


Condition or disease Intervention/treatment Phase
Primary Percutaneous Coronary Intervention Drug: Enoxaparin Phase 4

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prolonged Enoxaparin In Primary Percutaneous Coronary Intervention; A Pilot Pharmacodynamic Study
Actual Study Start Date : August 25, 2017
Actual Primary Completion Date : December 30, 2017
Actual Study Completion Date : March 30, 2018

Arm Intervention/treatment
Experimental: Enoxaparin
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
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.




Primary Outcome Measures :
  1. anti Xa activity change [ Time Frame: recruitment, baseline, 3 hrs from baseline, 6 hrs from baseline ]
    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.


Secondary Outcome Measures :
  1. P2Y12 Inhibition change [ Time Frame: recruitment, baseline, 3 hrs from baseline, 6 hrs from baseline ]
    Assess the level of P2Y12 inhibition in response to oral therapy. This will be achieved by performing the established VerifyNow P2Y12 assay. Although the delay in platelet inhibition is well established now, measuring P2Y12 inhibition is valuable in this case to ensure that adequate inhibition is achieved by the end of enoxaparin infusion. It would also provide useful information in case of complications such as stent thrombosis or bleeding.

  2. Fibrin Clot Formation change [ Time Frame: recruitment, baseline, 3 hrs from baseline, 6 hrs from baseline ]
    Assess the effects of the proposed regimen on fibrin clot formation. This will be done by thromboelastography (TEG) in whole blood and by turbidimetric assay in plasma

  3. Enoxaparin Regimen [ Time Frame: within 12 hours from baseline ]
    Obtain pilot data on the safety of the enoxaparin regimen by assessing bleeding rates 12 hours following PCI



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03146858


Locations
Layout table for location information
United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, United Kingdom, S5 7AU
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust

Publications of Results:
Layout table for additonal information
Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03146858     History of Changes
Other Study ID Numbers: STH19752
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No