A Study To Determine the Efficacy and Safety of REG1 Compared to Bivalirudin in Patients Undergoing PCI



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:5/5/2014
Start Date:September 2013
End Date:December 2015
Contact:Raul P Lima, MA, MBA
Email:regulate@regadobio.com
Phone:9085802100

Use our guide to learn which trials are right for you!

Trial Summary
Trial Overview
Inclusion Criteria

A Randomized, Open-Label, Multi-Center, Active-Controlled, Parallel Group Study To Determine the Efficacy and Safety of the REG1 Anticoagulation System Compared to Bivalirudin in Patients Undergoing Percutaneous Coronary Intervention

This study is designed to determine the efficacy of REG1 compared to bivalirudin in
preventing periprocedural ischemic complications and major bleeding in patients undergoing
PCI as a treatment for CAD. Bivalirudin has been studied in patients undergoing PCI in both
ACS (NSTEMI and unstable angina [UA]) and elective PCI. In comparison to UFH, bivalirudin
has shown similar rates of ischemic events while demonstrating a significant reduction in
bleeding and an improved net clinical benefit.

Evidence from previous studies indicates that pegnivacogin represents an extremely potent,
chemically unique anticoagulant that can be reversed by anivamersen across multiple
populations (refer to Section 1.2.2). The question that still remains is whether Factor IX
(FIX) inhibition by pegnivacogin can result in fewer ischemic events than a previously
studied agent while active control with anivamersen can preserve the benefit of reduced
bleeding. The purpose of this study is to evaluate REG1 in an adequately powered definitive
study with an open-label, multi-center, active-controlled, randomized design to answer that
question.


Inclusion Criteria:

1. The study population will consist of patients with CAD undergoing PCI. Three key
subgroups will be included

2. Willing and able to sign an Institutional Review Board/Ethics Committee (IRB/EC)
approved informed consent prior to any study-related activities;

3. Male or female age 18 or greater;

4. If female of childbearing potential, must have a negative urine or serum pregnancy
test or be post-menopausal for at least 1 year prior to randomization. Females of
childbearing potential must be practicing adequate birth control to be eligible. It
is the Investigator's responsibility for determining whether the patient has adequate
birth control for study participation;

5. Subject is able and willing to comply with the protocol and all study procedures

Exclusion Criteria:

1. Acute ST-segment elevation myocardial infarction within 48 hours of randomization;

2. Evidence of current clinical instability

3. Evidence of a contraindication to anticoagulation or increased risk of bleeding

4. Use of any investigational drug or device within 30 days of randomization or the
planned use of an investigational drug or device through EOS (Day 30 follow-up);

5. Use of the select antithrombotic agents

6. Baseline hemoglobin (Hgb) <9 g/dL or equivalent;

7. Baseline estimated glomerular filtration rate (GFR) ≤ 10 mL/min/1.73m² or currently
undergoing renal replacement therapy (hemodialysis or peritoneal dialysis);

8. Baseline platelet count <100,000/mm3;

9. Known allergy or intolerance to aspirin, to all available ADP/P2Y12 inhibitors
(clopidogrel, prasugrel, ticagrelor), or to bivalirudin or REG1 (or any of their
respective components);

10. The following planned procedures: a. Planned staged PCI procedure within 3 days
after randomization; b. Planned CABG or valve surgery within 30 days after
randomization;

11. Any other medical or psychiatric condition that in the Investigator's judgment
precludes participation in the study
We found this trial at
1
site
Black Hills Cardiovascular Research
Rapid City, South Dakota 57701
?
mi
from
Rapid City, SD
Click here to add this to my saved trials