Prolonged Enoxaparin In Primary Percutaneous Coronary Intervention; A Pilot Pharmacodynamic Study (PENNY PCI)
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|ClinicalTrials.gov Identifier: NCT03146858|
Recruitment Status : Completed
First Posted : May 10, 2017
Last Update Posted : April 19, 2018
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
|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)|
|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|
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.
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.
- 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.
- 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.
- 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
- 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
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
|Sheffield Teaching Hospitals NHS Foundation Trust|
|Sheffield, South Yorkshire, United Kingdom, S5 7AU|