Acute Peripheral Arterial Occlusion Clinical Trial
Official title:
A Phase 2, Randomized, Open-label (With Blinded Plasminogen Activator and Placebo Control Groups) Study to Evaluate the Effects of Different Intra-thrombus Infusion Regimens of Plasmin (Human) Compared to Plasminogen Activator and Placebo In Patients With Acute Lower Extremity Native Artery or Bypass Graft Occlusion
The primary purpose of this Phase 2 study is to optimize Plasmin delivery by comparing different delivery regimens in patients with peripheral arterial occlusion. The study includes a blinded plasminogen activator treatment group and a blinded plasminogen activator placebo group. The study will also assess safety and tolerability of Plasmin at 150 and 250 mg doses.
| Status | Active, not recruiting |
| Enrollment | 230 |
| Est. completion date | February 2016 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Unilateral limb ischemia - Society of Vascular Surgery Categories I and IIa - Onset of symptoms less than or equal to 14 days - Thrombosed infrainguinal bypass graft or native artery - Diagnosis by arteriography of occlusive thrombus in graft or artery - Ability to embed the infusion catheter into the thrombus - Women of childbearing potential must use contraception and have a negative pregnancy test Exclusion Criteria: - Any medical or social condition that may interfere with study participation - Women who are pregnant or lactating - Hemorrhagic stroke history - Thrombotic or embolic stroke or cerebrovascular events (including transient ischemic attack) within one year - Intracranial or spinal neurosurgery, or severe intracranial trauma in the last 3 months - Major surgery, organ biopsy, or major trauma within the past 10 days - Lumbar puncture or non-compressible arterial puncture in the past 10 days - Intraocular surgery within the past 10 days - Active gastrointestinal or organ bleeding - Uncontrolled arterial hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) - Known intracranial neoplasm, aneurysm, or arteriovenous malformation - Current bleeding diathesis - Platelet count <75 x 10e9/L - Active graft infection - Occlusion occurred within one month of synthetic graft placement - Occlusion occurred within 6 months of autologous graft placement - A sequential composite graft with dual outflows to correct multiple occlusions - Medically unable to tolerate an open vascular procedure - Known prothrombotic state - Hemoglobin <10.0 g/dL - Impaired renal function or renal disease that constitutes a contraindication to contrast angiography, including creatinine >2.0 mg/dL - Treatment with a full dose plasminogen activator (PA) within the last 48 hours - Treatment with a glycoprotein IIb/IIIa class of platelet inhibitor within the past 5 days - Treatment with oral anticoagulants, and with an international normalized ratio of >1.7 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Erasme Hospital, Brussels | Brussels | |
| Belgium | University Hospital Antwerp | Edegem | |
| Belgium | Ziekenhuis Oost Limburg, Campus St. Jan | Genk | Limburg |
| Belgium | Chirurgie UZ Leuven | Leuven | |
| Bulgaria | Clinic of Vascular Surgery and Angiology | Sofia | |
| Bulgaria | Tokuda Hospital Sofia | Sofia | |
| Czech Republic | Vascular Centre Vitkovicka Nemocnice | Ostrava - Vitkovice | |
| Czech Republic | Cevni Chirurgie, Nemocnice Na Homolce | Prague | |
| Czech Republic | IKEM, Kardiologicka klinika | Prague | |
| Czech Republic | University Hospital Kralovske Vinobrady | Prague | |
| Czech Republic | Chirurgicka klinika IPVZ | Usti nad Labem | |
| Germany | Universitätsklinikum Bonn, Radiologische Universitätsklinik | Bonn | |
| Germany | Universitäts GefäßCentrum Uniklinikum Dresden | Dresden | |
| Germany | Klinik für Innere Medizin I - Angiologie / Kardiologie | Leipzig | |
| India | Life Care Institute of Medical Sciences and Research | Gujarat | |
| India | Gokula Metropolis Clinical Research Centre, M. S. Ramaiah Hospital | Karnataka | |
| Peru | Centro de Investigación y Atención Cardiovascular | Lima | |
| Peru | Hospital Nacional Edgardo Rebagliati Martins | Lima | |
| Peru | Hospital Nacional Guillermo Almenara Irigoyen-EsSalud | Lima | |
| Peru | Instituto Neuro Cardiovascular de las Americas | Lima | |
| Poland | Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu | Bytom | |
| Poland | Malopolskie Centrum Sercowo-Naczyniowe PAKS American Heart of Poland Sp. z o.o | Chrzanow | |
| Poland | Uniwersyleckie Centrum Kliniczne | Gdansk | |
| Poland | Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu | Poznan | |
| Poland | Zaklad Opieki Zdrowonej Ministerstwa Spraw Wewnetrznych i Administracji w Poznaniu | Poznan | |
| Poland | Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie | Szczecin | |
| Romania | Institutul de Urgenta pentru Boli Cardiovasculare "Prof.Dr.C.C.Iliescu" | Bucuresti | |
| Romania | Institutul Inimii "Nicolae Stancioiu" Cluj-Napoca | Cluj-Napoca | |
| Romania | Inst.de Boli Cardiovasculare "Prof.I.M.Georgescu" Iasi | Iasi | |
| Romania | Institutul de Boli Cardiovasculare si Transplant Mures | Targu Mures | |
| Serbia | Institut za kardiovaskularne bolesti Dedinje | Beograd | |
| Serbia | Klinicki Centar Srbije | Beograd | |
| Serbia | Klinicki Centar Nis | Nis | |
| Serbia | Klinicki Centar Vojvodine | Novi Sad | |
| Slovakia | Oddelenie diagnostickej a intervencnej radiologie, The National Institute of Cardiovascular Diseases | Bratislava | |
| Slovakia | The Eastern Slovak Institute of Cardiovascular Diseases | Kosice | |
| Spain | Fundacion Hospital Alcorcon | Alcorcon | |
| United States | Kaleida Health System | Buffalo | New York |
| United States | Cleveland Clinic | Cleveland | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Grifols Therapeutics Inc. |
United States, Belgium, Bulgaria, Czech Republic, Germany, India, Peru, Poland, Romania, Serbia, Slovakia, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The proportion of subjects with >50% thrombolysis | The proportion of subjects with >50% thrombolysis at the end of treatment compared to baseline by arteriography. | 5 hours | No |
| Secondary | The incidence of major and minor bleeding events, deaths, adverse events, serious adverse events, and abnormal laboratory values as a measure of safety and tolerability. | The incidence of major and minor bleeding events, deaths, adverse events, serious adverse events, and abnormal laboratory values as a measure of safety and tolerability. | 30 days | Yes |