Patients sought for anti-coagulation study at Backus
March 16, 2011
When a blood clot forms as part of the body’s normal repair process, there is little cause for alarm. But when a clot forms when it is not needed, it can have potentially significant consequences.
The threat from blood clots is ever-present, especially following surgeries, and many doctors will prescribe an anticoagulant medication such as warfarin for six to 12 months for at-risk patients to help speed the body’s natural process of thinning the clot.
But what happens when that time frame is over? Does that mean the threat is over? Not always.
That’s the reason behind a clinical trial led by Jan Akus, MD, Medical Director of the Anti-Coagulation Clinic being undertaken at Backus for a new anticoagulant called apixaban. If approved, apixaban could be tacked on to the end of a warfarin regimen to extend the treatment of known blood clots or help prevent future ones.
The study includes patients who have had a naturally occurring blood clot and have been prescribed anti-coagulation treatment. Upon completion of the standard treatment, patients would enter the study comparing two doses of apixaban to a placebo in the prevention of recurrent clots.
While warfarin is effective and the current standard procedure in treating and preventing blood clots, long-term use of the drug can cause complications, which is why it is closely monitored by the prescribing doctor and limited in its duration of use.
“Warfarin has many drug interactions,” said Study Coordinator Paula Provost. “It can get tedious for patients because they really have to watch their diet and new meds, even ones that are over the counter.”
Backus is participating in a Phase III study which looks at the efficacy of apixaban in patients who have blood clots. The hospital is hoping to identify one patient per month who meets the candidate criteria. Every patient will be followed for a year, meaning it will still be several years before the main studies are complete.
And while the study will eventually help everyone, having the clinical trials right here at Backus adds an element of immediacy that can’t be found elsewhere.
“It’s good to be involved in the advancement of medicine,” said Michael Smith, PharmD, Clinical Coordinator of the Pharmacy Department and a member of the trial team. “If we weren’t a part of it, the community wouldn’t have access to these leading edge medical discoveries.”
If you feel you may qualify for this study, or have a patient who may qualify, please contact Paula Provost at 860-892-6936.
Prospective criteria would include:
• Symptomatic deep vein thrombosis or a pulmonary embolism and currently in a 6- to 12-month period of anticoagulation.
• A DVT or PE that was not due to reversible cause (i.e. surgery)
• A risk factor for recurrence, but not indicated for long-term or indefinite treatment of anti-coagulation.