Bleeding
Title:
Purpose: To evaluate the safety and efficacy of Beriplex® P/N so that it can be licensed and sold in the United States. The study is
designed to show that Beriplex® P/N is at least as effective as (or no worse than) human plasma in returning thinned blood
towards normal.
Eligibility Male and female patients in the ICU at Sinai Hospital of Baltimore, 18 years of age or older who have received oral vitamin
K-antagonist therapy and have acute major bleeding.
Principal Investigator: Rubenfeld, Joshua
Phase: III
For more information, contact: Highfield, David
Telephone Number:
Email dhighfield@pccabpa.com
Approved Enrollment Number: 6
Current Enrollment: 0
Cardiovascular Disease
Title:
Purpose: To determine the safety and efficacy of the Absolute Pro Peripheral Self-Expanding Stent System (Absolute Pro stent) and
the Omnilink Elite Peripheral Balloon-Expandable Stent System (Omnilink Elilte stent) in subjects with atherosclerotic de
novo or restenotic lesions in the native common iliac artery and/or native external iliac artery.
Eligibility Subject must be at least 18 and less than 90 years of age, and have had a history of symptomatic claudication (Rutherford
Becker Clinical Category 2-3) or ischemic rest pain (Rutherford Becker Clinical Category 4).
Principal Investigator: Prewitt, Kerry C.
Phase: III
For more information, contact: Dudek, Audrey
Telephone Number: 410-583-1170
Email adudek@midatalanticcardo.com
Approved Enrollment Number: 10
Current Enrollment: 0
Cardiovascular Disease
Title:
Purpose: To identify the optimal duration of dual antiplatelet therapy in subjects who undergo stenting procedures.
Eligibility Study subjects with ischemic heart disease due to stenotic lesions in either native coronary arteries or coronary artery bypass
grafts undergoing PCI with stent placement and no contraindications to prolonged DAPT are eligible to be enrolled in this
study. Subjects may have multi-vessel treatment.
Principal Investigator: Gurbel, Paul A.
Phase: IV
For more information, contact: Bliden, Kevin
Telephone Number: 410-601-4795
Email kbliden@lifebridgehealth.org
Approved Enrollment Number: 50
Current Enrollment: 0
Cardiovascular Disease
Title:
Purpose: To provide evidence that point-of-care genetic and platelet function testing can be successfully used to identify patients at
ischemic risk and alter therapy using an algorithm to guide clinicians in the management of antiplatelet therapy.
Eligibility Subjects, 18 years of age or older, who have ischemic heart disease due to stenotic lesions in either native coronary arteries or
coronary artery bypass and undergo PCI with stent placement and have no contraindication to prolonged dual antiplatelet
therapy (=1 year) are eligible to be in the study.
Principal Investigator: Gurbel, Paul A.
Phase: III
For more information, contact: Bliden, Kevin
Telephone Number: 410-601-4795
Email kbliden@lifebridgehealth.org
Approved Enrollment Number: 1500
Current Enrollment: 0
Carotid Artery Disease
Title:
Purpose: To collect data about patients' medical experiences and conditions following treatment of carotid stenosis using one of Abbot
Vascular's carotid stent systems and embolic protection systems.
Eligibility Anyone that has a blockage of the carotid artery and is considered at high risk for carotid endarterectomy surgery.
Principal Investigator: Mastali, Kourosh
Phase: IV
For more information, contact: Dudek, Audrey
Telephone Number: 410-583-1170
Email adudek@midatalanticcardo.com
Approved Enrollment Number: 50
Current Enrollment: 0
Coronary Heart Disease
Title:
Purpose: To evaluate the safety and efficacy of the REG1 Anticoagulation System in ACS patients undergoing cardiac catheterization
by determination of the clinically acceptable dose range of RB007, which can be used to reverse the anticoagulant effect of
RB006.
Eligibility Male or female subject, 18 - 85 years of age (inclusive) who are admitted for Acute Coronary Syndrome at Sinai Hospital's
Heart Center to undergo cardiac catheterization.
Principal Investigator: Gurbel, Paul A.
Phase: II
For more information, contact: Bliden, Kevin
Telephone Number: 410-601-4795
Email kbliden@lifebridgehealth.org
Approved Enrollment Number: 25
Current Enrollment: 0
Coronary Heart Disease
Title:
Purpose: To evaluate the effect of dalcetrapib treatment for 2 years on atherosclerotic disease progression - as assessed by coronary
intravascular ultrasound (IVUS) and carotid B-mode ultrasound - in patients with coronary artery disease (CAD).
Eligibility Male and female patients over 18 years of age scheduled for clinically indicated coronary angiography and possible ad hoc
percutaneous coronary intervention (PCI). Evidence-based management of LDL-C cholesterol, at a minimum to include
medical and dietary treatment to a target level of <100 mg/dl (<2.6 mmol/L) by the time of randomization, and ideally to
include treatment to a target level <70 mg/dl (<1.8 mmol/L). Patients with an LDL-C level above greater than or =100 mg/dL
(greater than or =2.6 mmol/L) may be randomized if they cannot reach the target goal of less than 100 mg/dL despite an
intensive statin regimen, are on a maximum tolerated dose of statin as determined by the investigator, or are unable to tolerate
statins.
Principal Investigator: Herzog, William R.
Phase: III
For more information, contact: Akhtar, Mehro
Telephone Number: 443-276-9031
Email makhtar@cvspecialists.net
Approved Enrollment Number: 18
Current Enrollment: 0
Coronary Heart Disease
Title:
Purpose: To determine the effects of clopidogrel on fibrin, thrombin, and platelet aggregation in patients with coronary artery disease
(narrowing of heart vessels). The effects of clopidogrel on patients with coronary artery disease who have received stents as
opposed to those with coronary artery disease who are on chronic aspirin therapy and have not received the stents will also
be determined.
Eligibility Men and women aged 18 years or older with coronary artery disease are eligible to participate.
Principal Investigator: Gurbel, Paul A.
Phase: I
For more information, contact: Bliden, Kevin
Telephone Number: 410-601-4795
Email kbliden@lifebridgehealth.org
Approved Enrollment Number: 100
Current Enrollment: 24
Coronary Heart Disease
Title:
Purpose: To investigate whether the combination of aliskiren added to other drugs given as part of the standard care to patients for
treatment of coronary artery disease are more effective in slowing the rate of the narrowing in the arteries in the heart than just
the standard drugs alone.
Eligibility Men and women less than 55 years of age with coronary artery disease, demonstrated by catheterization/IVUS, and blood
pressure in the high normal range.
Principal Investigator: Herzog, William R.
Phase: III
For more information, contact: Akhtar, Mehro
Telephone Number: 443-276-9031
Email makhtar@cvspecialists.net
Approved Enrollment Number: 5
Current Enrollment: 4
Cushing's Syndrome
Title:
Purpose: To assess the safety and efficacy of CORLUX™ (mifepristone) in treating the signs and symptoms of Cushing’s syndrome.
CORLUX™ (mifepristone) blocks the effects of cortisol, which may improve the symptoms and signs of Cushing’s
syndrome.
Eligibility This study will enroll patients with Cushing’s syndrome who have not had effective results from surgical or radiation
treatment. The study may also enroll Cushing’s patients who cannot undergo surgery and who would still benefit from
medical therapy.
Principal Investigator: Fein, Henry
Phase: III
For more information, contact: Orpia, Alanvin
Telephone Number: 410-601-0960
Email aorpia@lifebridgehealth.org
Approved Enrollment Number: 3
Current Enrollment: 1
Deep Vein Thrombosis
Title:
Purpose: To find out if the drug that is under study, rivaroxaban (BAY 59-7939), given as a tablet twice daily for the first three (3)
weeks and thereafter only once a day, is safe and effective compared to the standard treatment of deep vein thrombosis and
pulmonary-embolism (which is enoxaparin (Lovenox) injections plus warfarin tablets).
Eligibility Patients in Sinai Hospital of Baltimore with a confirmed diagnosis of deep vein thrombosis and/or pulmonary embolism may
be eligible to participate in this study. The principal investigator will thoroughly explain all eligibility criteria and will also
evaluate patients for any exclusion criteria before they can participate. The study is also taking place worldwide in
approximately 30 different countries, involving 300-350 hospitals and 6200 patients in total. The principal investigator is
expecting to enroll 20 subjects in Sinai Hospital of Baltimore.
Principal Investigator: Albrecht, Charles
Phase: III
For more information, contact: Orpia, Alanvin
Telephone Number: 410-601-0960
Email aorpia@lifebridgehealth.org
Approved Enrollment Number: 20
Current Enrollment: 4
Deep Vein Thrombosis
Title:
Purpose: To compare edoxaban with warfarin to see if it is safe and effective in the treatment of DVT and/or PE.
Eligibility Subjects must be 18 years or older, diagnosed with a DVT and/or PE and be able to comply with the study requirements.
Principal Investigator: Cunanan-Bush, Marianne
Phase: III
For more information, contact: Orpia, Alanvin
Telephone Number: 410-601-0960
Email aorpia@lifebridgehealth.org
Approved Enrollment Number: 10
Current Enrollment: 0
Title:
Purpose: To compare edoxaban with warfarin to see if it is safe and effective in the treatment of DVT and/or PE.
Eligibility Subjects must be 18 years or older, diagnosed with a DVT and/or PE and be able to comply with the study requirements.
Principal Investigator: Ravi, Chaitanya Kumar
Phase: III
For more information, contact: Orpia, Alanvin
Telephone Number: 410-601-0960
Email aorpia@lifebridgehealth.org
Approved Enrollment Number: 10
Current Enrollment: 0
Gastric Ulcers
Title:
Purpose: To demonstrate that PA32540 causes fewer gastric ulcers in subjects at risk for developing aspirin-associated gastric ulcers
compared to enteric coated (EC) aspirin 325 mg. To demonstrate that PA32540 causes fewer gastric and/or duodenal ulcers in
subjects at risk for developing aspirin-associated ulcers compared to enteric coated (EC) aspirin 325 mg. To compare
between treatments, the proportion of subjects with "Treatment Success", defined as those subjects without gastric ulcers and
without upper gastrointestinal (UGI) adverse events leading to discontinuation.
Eligibility Patients who have been using daily aspirin 325 mg at least three months prior to enrollment for secondary prevention of
cardio- and cerebrovascular events and who have undergone coronary revascularization or carotid endarterectomy at least six
months prior to enrollment. Patients who are over 60 years of age at the time of dosing, or 18-60 years of age and have a
history of a documented gastric or duodenal ulcer within the past five years may be eligible for the study.
Principal Investigator: Gurbel, Paul A.
Phase: III
For more information, contact: Bliden, Kevin
Telephone Number: 410-601-4795
Email kbliden@lifebridgehealth.org
Approved Enrollment Number: 20
Current Enrollment: 0
Heart Failure
Title:
Purpose: To find out if the drug that is under study, nesiritide (tradename Natrecor) as compared to placebo, when each is administered
in addition to standard treatment for acute decompensated heart failure, will help improve patient's breathing difficulties,
reduce the chance of being readmitted to the hospital and will live longer.
Eligibility Patients are eligible to participate in this study if they are hospitalized in Northwest Hospital Center for the management of
acute decompensated heart failure or diagnosed with acute decompensated heart failure within 48 hours after being
hospitalized for another reason. The principal investigator will thoroughly explain all eligibility criteria and will also evaluate
patients for any exclusion criteria before they can participate. Approximately 7,000 subjects will take part in the study from
approximately 700 hospitals, clinics and medical offices around the world. The principal investigator is expecting to enroll at
least 1 patient a month in Northwest Hospital Center.
Principal Investigator: Ravi, Chaitanya Kumar
Phase: III
For more information, contact: Orpia, Alanvin
Telephone Number: 410-601-0960
Email aorpia@lifebridgehealth.org
Approved Enrollment Number: 12
Current Enrollment: 10
Venous Thromboembolism
Title:
Purpose: To assess if 10 mg rivaroxaban (study drug), taken once a day as a tablet is safe and can help prevent blood clots in patients
who have been hospitalized for a medical illness. The study drug will be compared to enoxaparin.
Eligibility Male and female patients 40 years and older, hospitalized due to certain medical conditions and who are at risk of developing
blood clots.
Principal Investigator: Albrecht, Charles
Phase: III
For more information, contact: Tran, Chi
Telephone Number: 410-601-0960
Email ctran@lifebridgehealth.org
Approved Enrollment Number: 10
Current Enrollment: 2