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 INTERVENTIO
- Conditions
- blockage in an arteryHeart disease10011082
- Registration Number
- NL-OMON40245
- Lead Sponsor
- Regado Biosciences, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 405
1. The study population will consist of patients with CAD undergoing PCI. Three key subgroups will be included as follows:
a. Subgroup A: Patients with ischemic symptoms at rest and positive cardiac biomarkers (troponin I or T or creatine kinase-MB) related to an acute coronary syndrome event within 7 days;
b. Subgroup B: Patients not meeting criteria for Subgroup A with at least one of the following risk factors:
* Current presentation with an acute coronary syndrome
with positive cardiac biomarkers > 7 days prior to randomization
* Current presentation with unstable angina (ACS without positive
cardiac biomarkers)
* Age >70 years
* Diabetes
* Chronic kidney disease (estimated CrCl < 60 mL/min)
* Planned multivessel PCI
* Prior CABG surgery
* Peripheral vascular disease;
c. Subgroup C: Patients with negative cardiac biomarkers and no risk factor, thereby not meeting criteria for Subgroup A or B;
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 and males with partners of childbearing potential must
be using effective contraception to be eligible. Women who are nursing or lactating should not nurse while in the study as
the effects of this drug on nursing has not been studied. It is the Investigator*s responsibility for determining whether the patient is
using effective contraception and refraining from nursing for study participation;
5. Subject is able and willing to comply with the protocol and all study procedures,
including but not limited to the 20 + 4 hour blood draw, Endpoint (Day 3 +7), End-of-Study (Day 30), and 6-month vital status assessments.
1. Acute ST-segment elevation myocardial infarction within 48 hours of randomization; of the following:
2. Evidence of current clinical instability including the following:
a. Sustained systolic blood pressure <90 mm Hg or cardiogenic shock;
b. Suspected acute myocarditis, pericarditis, endocarditis, or cardiac tamponade;
c. Suspected dissecting aortic aneurysm;
3. Evidence of a contraindication to anticoagulation or increased risk of bleeding such as:
a. Any evidence or history of intracranial bleeding or intracranial aneurysm;
b. Known hypercoagulable state, including treatment for malignancy (excluding basal cell skin carcinoma) in the past year, or coagulopathy with abnormal bleeding tendency;
c. History of intraocular hemorrhage other than due to diabetic retinopathy;
d. History of thrombocytopenia associated with abnormal bleeding;
e. History of thrombocytosis associated with a thrombotic event;
f. Severe trauma, fracture, major surgery, or biopsy of a parenchymal organ within 3 months;
g. Prolonged cardiopulmonary resuscitation within 3 months;
h. Major gastrointestinal bleeding within 3 months;
i. Spontaneous genitourinary bleeding within 3 months;
j. Any planned additional invasive procedure within 30 days after randomization;
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 following antithrombotic agents:
a. Fibrinolytic agents within 48 hours;
b. GP IIb/IIIa inhibitors within 24 hours;
c. Bivalirudin within 24 hours
d. Prior exposure to any component of REG1;
6. Baseline hemoglobin (Hgb) <9 g/dL or equivalent;
7. Renal impairment as determined by any one of the following:
a. Baseline estimated glomerular filtration rate (GFR) * 10 mL/min/1.73m²;
b. Currently undergoing renal replacement therapy (hemodialysis or peritoneal dialysis);
c. Degree of renal impairment for which use of bivalirudin is prohibited or contraindicated per local label instructions;
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 30 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Endpoint: The primary efficacy endpoint is the composite of death,<br /><br>nonfatal myocardial infarction, nonfatal stroke and urgent TLR through Day 3. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary Endpoints:<br /><br>1. The composite of death, nonfatal myocardial infarction, nonfatal stroke,<br /><br>urgent TLR and stent thrombosis (including intra-procedural) through Day 3;<br /><br>2. Major non-CABG bleeding (BARC Types 3 and 5) through Day 3;<br /><br>3. The composite of death, nonfatal myocardial infarction, nonfatal stroke and<br /><br>urgent TLR through Day 30;<br /><br>4. The composite of death, nonfatal myocardial infarction, nonfatal stroke and<br /><br>urgent TLR in Subgroup A (cardiac biomarker-positive patients) through Day 3;<br /><br>5. The composite of death, nonfatal myocardial infarction, nonfatal stroke and<br /><br>urgent TLR in Subgroups B and C (cardiac biomarker-negative patients) through<br /><br>Day 3;<br /><br>6. Major non-CABG bleeding (BARC Types 3 and 5) through Day 30.</p><br>