Serp-1 for the Treatment of Acute Coronary Syndrome

Status Terminated

Clinical Trial Summary

Males and females aged 18-80 years who present with ACS (unstable angina and non ST-elevation MI) defined as one or more episodes of angina lasting at least 5 minutes in the last 24 hours before admission and greater than 0.05 mV of presumed new ST-segment depression in at least 2 contiguous ECG leads OR, angina and per confirmatory angiogram, has been scheduled for percutaneous coronary angioplasty. The primary objective of this study is to evaluate the safety of Serp-1 injection when administered in 3 daily doses to patients undergoing conventional therapy for Acute Coronary Syndrome (ACS) requiring early intervention.

Clinical Trial Description

A total of 72 subjects will be enrolled, separated into 3 dose groups and centrally randomized in a 3:1 ratio of Serp-1 injection to placebo control.Subjects will receive Serp-1 by intravenous (IV) bolus injection daily for 3 days, at dose levels of 5.0, 15, and 50 ug/kg/dose or placebo (0.9% normal saline) added to any prescribed therapy for ACS. Serp-1 will be administered as a single IV bolus injection. The initial IV bolus dose is administered immediately preceding the PCI procedure with subsequent doses administered 24 and 48 hours later.Subjects will be evaluated for adverse events, serum inflammatory markers and restenosis rates at 6 months post-dose. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00243308
Study type	Interventional
Source	Viron Therapeutics Inc
Contact
Status	Terminated
Phase	Phase 2
Start date	October 2005
Completion date	December 2008

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05563701` - Evaluation of the LVivo Image Quality Scoring (IQS)
Completed	`NCT04097912` - Study to Gather Information to What Extent Patients Follow the Treatment Regimen of Low-dose Aspirin for Primary and Secondary Prevention of Diseases of the Heart and Blood Vessels
Withdrawn	`NCT03906812` - A Randomized Trial of Telemetry Compared With Unmonitored Floor Admissions in ED Patients With Low-Risk Chest Pain	N/A
Not yet recruiting	`NCT03610529` - CardioSenseSystem Compared Study Regarding Efficacy and Safety in the Monitoring of ECG	N/A
Completed	`NCT01826552` - Comparison of the Angiographic Result of the Orsiro Hybrid Stent With Resolute Integrity Stent	Phase 4
Completed	`NCT01688648` - Comparison Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft	N/A
Completed	`NCT01709669` - The Impact of Gratitude on Biology and Behavior in Persons With Heart Disease	N/A
Completed	`NCT01171404` - Study Evaluating How Patients With Acute Coronary Syndrome Are Managed During 2 Years After Discharge	N/A
Completed	`NCT01020383` - Comparative Study of ALX-0081 Versus GPIIb/IIIa Inhibitor in High Risk Percutaneous Coronary Intervention (PCI) Patients	Phase 2
Completed	`NCT01167582` - Myocardial Ischemia and Transfusion Pilot	Phase 3
Completed	`NCT00449826` - Risk Stratification of Non ST Elevation ACS With Computed Tomographic Angiography (REACT)	N/A
Terminated	`NCT00355992` - The Ischemia Modified Albumin In Diagnosing Ischemic New Events	N/A
Completed	`NCT00263263` - RRISC Study: Reduction of Restenosis In Saphenous Vein Grafts With Cypher Sirolimus-Eluting Stent.	Phase 2
Active, not recruiting	`NCT04929496` - Physiology as Guidance to Evaluate the Direct Impact of Coronary Lesion Treatment: The PREDICT Study	N/A
Completed	`NCT03103620` - Safety and Effectiveness Evaluation of COBRA PzF Coronary Stent System: A Post Marketing Observational Registry
Completed	`NCT04648306` - Restore EF Observational Study
Not yet recruiting	`NCT03266289` - Evaluation of Short Term Outcome of Different Bifurcation Stenting Techniques at Assuit University Cath. Lab	N/A
Not yet recruiting	`NCT04403048` - Drug Coated Balloon for Side Branch Treatment vs. Conventional Approach in True Bifurcation Coronary Disease: PRO-DAVID	N/A
Recruiting	`NCT02748603` - Appropriateness of Coronary Angioplasty in PAtients With isCHEmic Heart Disease	N/A
Completed	`NCT01774838` - Vasoactive and Anti-inflammatory Effects of Prasugrel in Acute Coronary Syndrome	Phase 3