About Clinical Research
What is a clinical (research) trial?
This is a study in which participants (volunteers) evaluate a new therapy to see if it shows promising effects that may help patients in the future. At the same time, we are looking for potential side effects that patients may experience while on the therapy. Our involvement in these trials allows us to provide our patients with access to leading edge treatments only available while participating in a clinical trial.
Why are clinical trials important?
Clinical trial participation is crucial for development of new medications to treat heart disease. Through research we are able to assist scientists with:
- The development of new treatments that may prove to be safer or more effective than medications that are currently available.
- Discovering new, safe and effective medications or treatments for conditions that currently have no proven treatment.
- Seeking new uses for medications or treatments that are currently available.
What is informed consent?
As a participant in a clinical trial, you will be given all available information in language you understand to be able to make an informed decision concerning your willingness to participate in a clinical trial. You will have the opportunity to have all of your questions answered to your satisfaction prior to being asked to provide your written signature of consent. The ultimate decision to participate lies with you and you are free to withdraw your consent at any time. After you have signed consent, the original consent form will be maintained with your research record. A photocopy of the consent form will be furnished to you to keep.
Who can participate in Clinical Trials?
Each clinical trial has its own specific patient criteria. Every enrolled patient must meet these criteria in order to be considered for the trial. These criteria are created by the sponsor of the trial and must be adhered to in order to ensure the safety of the enrolled patient and integrity of the trial being conducted. Patients enrolled in a clinical trial are expected to adhere to the study guidelines established with regard to study visits and study medication administration.
Questions to ask your doctor.
We encourage our study patients to consult with their primary care physician and/or family members to discuss trial participation. Your primary care doctor may opt to contact the study doctor to gain a better understanding of the trial you are interested in participating in. Their input may prove to be helpful in assisting you to decide if trial participation is the best option for you.
Who can I contact to find out more about available clinical trials and if I may qualify for any current trials?
If you have a heart problem and would like to be placed in our Registry for Clinical Trial Candidates, you may contact our research office at 215-750-7818 EXT. 39 or send an email to our Research Manager, Amy Doman RN, BSN @ adoman@comprehensivecardiology.com. Please leave your name, day time phone number, and brief information about your heart problem. We will retain this information in our potential patient database. Our research staff will contact you should we have a clinical trial that your name and information will not be given to any other entity.
Current Clinical Trials at Comprehensive Cardiology:
Atrial Fibrillation
AVERROES: “Apixaban Versus Acetylsalicylic Acid (ASA) to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or are Unsuitable for Vitamin K Antagonist Treatment: A Randomized Double Blind Trial.”
Principal Investigator: Ronald Fields, MD, F.A.C.C.
ENROLLMENT OPEN
RE-LY: “Randomized Evaluation of Long term anticoagulant therapy comparing the efficacy and safety of two blinded doses of dabigatran etexilate with open label warfarin for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation: prospective, multi-centre, parallel-group, non-inferiority trial. Principal Investigator: Ronald Fields, MD, F.A.C.C.
ENROLLMENT CLOSED
Coronary Artery Disease
RE-DEEM: “Randomized Dabigatran Etexilate dose finding study in patients with acute coronary syndromes post index Event with additional risk factors for cardiovascular complications also receiving aspirin and clopidogrel: Multi-centre, prospective, placebo controlled, group dose escalation trial”.
Principal Investigator: Ronald Fields, MD, F.A.C.C.
ENROLLMENT OPEN
A Randomized, Double-Blind, Double-Dummy, Parallel Group, Phase 3 Efficacy and Safety Study of CGT-2168 Compared with Clopidogrel to Reduce Upper Gastrointestinal Events Including Bleeding and Symptomatic Ulcer Disease Principal Investigator: Rakesh, Shah, MD
ENROLLMENT PENDING
Diabetics with Hyperlipidemia
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 36-week study to evaluate the Efficacy and Safety of Extended Release (ER) Niacin /Laropiprant in Patients with Type 2 Diabetes Mellitus.
Principal Investigator: Ronald Fields, MD, F.A.C.C.
ENROLLMENT CLOSED
