NCT00289042 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Klein AL, Grimm RA, Murray RD, Apperson-Hansen C, Asinger RW, Black IW, Davidoff R, Erbel R, Halperin JL, Orsinelli DA, Porter TR, Stoddard MF; Assessment of Cardioversion Using Transesophageal Echocardiography Investigators
Use of transesophageal echocardiography to guide cardioversion in patients with atrial fibrillation. N Engl J Med. 2001 May 10;344(19):1411-20.
Murray RD, Deitcher SR, Shah A, Jasper SE, Bashir M, Grimm RA, Klein AL
Potential clinical efficacy and cost benefit of a transesophageal echocardiography-guided low-molecular-weight heparin (enoxaparin) approach to antithrombotic therapy in patients undergoing immediate cardioversion from atrial fibrillation. J Am Soc Echocardiogr. 2001 Mar;14(3):200-8.
Murray RD, Shah A, Jasper SE, Goodman A, Deitcher SR, Katz WE, Malouf JF, Stoddard MF, Grimm RA, Klein AL; ACUTE II pilot study
Transesophageal echocardiography guided enoxaparin antithrombotic strategy for cardioversion of atrial fibrillation: the ACUTE II pilot study. Am Heart J. 2000 Jun;139(6):E1-7.

The Use of Enoxaparin Compared to Unfractionated Heparin for Short Term Antithrombotic Therapy in Atrial Fibrillation Patients Undergoing TEE Guided Cardioversion: Assessment of Cardioversion Using Transesophageal Echocardiography (ACUTE) II Randomized Multicenter Study

Details for clinical trial NCT00289042

Clinical trial NCT00289042 - References