- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03568838
Prolonged Enoxaparin in Primary Percutaneous Coronary Intervention (PENNYWISE)
Prolonged Enoxaparin in Primary Percutaneous Coronary Intervention Compared With Standard of Care Therapy - The PENNYWISE Feasibility Study
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Delayed absorption of oral P2Y12 inhibitors in patients undergoing primary percutaneous coronary intervention (PPCI) may increase the risk of stent thrombosis. Parenteral treatment is needed mitigate this risk.
We have recently shown a novel regimen of enoxaparin (bolus 0.75 mg/kg followed by an infusion of 0.75 mg/kg/6h) to provide consistent antithrombotic effects until the end of the infusion (1). We have also demonstrated the high prevalence of delayed platelet inhibition in opiate-treated patients (1).
This is a feasibility study for a larger randomised controlled trial (RCT). We aim to assess recruitment rate and collect pilot data on safety and efficacy. This will be a single-centre, open-label RCT comparing this novel regimen of enoxaparin to the local standard-of-care which usually consists of unfractionated heparin and a glycoprotein IIb/IIIa inhibitor. The study population will be opiate-treated patients undergoing PPCI. Pre PPCI, patients will be allocated in 1:1 ratio using a simple randomisation method using sealed envelopes, to either enoxaparin 0.75 mg/kg bolus followed by 0.75 mg/kg infusion over 6 hours (n=50) or the standard-of-care of UFH and tirofiban (n=50).
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
-
-
South Yorkshire
-
Sheffield, South Yorkshire, Royaume-Uni, S5 7AU
- Sheffield Teaching Hospitals NHS Foundation Trust
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age >18
- Confirmation of the diagnosis of STEMI by the clinical team on the basis of history and ECG changes
- Intention to proceed with PPCI
- Treated with opiates for analgesia
- Feasibility to obtain informed verbal consent pre PPCI
Exclusion Criteria:
- Active bleeding that cannot be controlled by local measures
- Pregnant patients
- Patients with end-stage renal failure requiring renal replacement therapy
- Patients with cardiogenetic shock
- Known thrombocytopenia (Platelet count <100,000)
- 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
- known hypersensitivity to benzylalcohol
- Patients with known acute bacterial endocarditis
- Known active gastric or duodenal ulceration
- 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
- Current participation, or participation within the last month, in an interventional clinical trial.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Enoxaparin
Patients allocated to the experimental arm will receive a parenteral (IA/IV) bolus dose of enoxaparin.
|
Patients allocated to the experimental arm will receive a parenteral (IA/IV) bolus dose of enoxaparin (0.75 mg/kg) pre PPCI followed by an infusion of 0.75 mg/kg over a 6-hour period to be started as soon as possible when PPCI starts.
|
Aucune intervention: Standard Therapy
Patients randomised to the standard therapy arm will receive treatment as guided by the treating cardiologist in line with the local standard-of-care, usually consisting of UFH and a GPI.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Recruitment Rate
Délai: Through study completion, average 1 year
|
Recruitment rate over the study period
|
Through study completion, average 1 year
|
Bleeding rates within 24 hours
Délai: Through study completion, average 1 year
|
These rates will be compared between the two treatment groups.
Trivial bleeding related to access site will be excluded.
Details on bleeding events will be collected and subsequently classified according to BARC types 2-5
|
Through study completion, average 1 year
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Acute stent thrombosis rate in each treatment arm
Délai: Through study completion, average 1 year
|
Acute stent thrombosis rate in each treatment arm (within 24 hours).
These rates will be compared between the two treatment groups.
|
Through study completion, average 1 year
|
Rates of ST-segment resolution in each treatment arm
Délai: Through study completion, average 1 year
|
Comparison will be undertaken between presentation ECG and ECG performed 1 hour post PPCI.
We will compare rates of ST segment resolution between the two treatment groups.
|
Through study completion, average 1 year
|
Rates of the composite outcomes
Délai: Through study completion, average 1 year
|
Rates of the composite outcome of recurrent myocardial infarction, ischaemic stroke or cardiovascular death within 30 days of STEMI.
These rates will be compared between the two treatment groups.
|
Through study completion, average 1 year
|
1-year mortality rates
Délai: Through study completion, average 1 year
|
These will be compared between the two groups.
|
Through study completion, average 1 year
|
Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Robert Storey, Sheffield Teaching Hospitals NHS FT
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- STH19902
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .