|CLEAR3 - Excluded Med Time Windows Version:11-May-12|
Graphic showing the allowed and excluded medications in the CLEAR III trial and the time window over which they are disallowed. Medications mentioned: aspirin, dabigatran / Pradaxa®, clopidogrel / Plavix®, warfarin / Coumadin®, low molecular weight heparins (enoxaparin/Lovenox®, dalteparin/Fragmin®, etc.), heparin, rtPA (alteplase, retiplase), urokinase, desmoteplase, and streptokinase.
New to protocol v3: During dosing, study center standard of care policies may govern the use of DVT prophylaxis. In the green area note the allowable use of unfractionated heparins for DVT prophylaxis during the acute treatment and follow-up periods. Heparin flushes of systemic lines are also permitted. Please, if your must flush the IVC, use only normal saline flushes. Please do not administer any thrombolytic agent through any IVC. These agents include urokinase, retiplase, desmotoplase, and rt-PA.
In the red area, note there are certain drugs that are not permitted during the study article administration.
During dosing, please do not use low molecular weight heparins. You may start low molecular weight heparins a full 72 hours after the last dose of test article. When doing so, please limit to less than 30 mg per day.
Further prohibited drugs include all antithrombotic agents, antiplatelet agents, Glycoprotein IIb/IIIa inhibitors, ASA, Clopidogrel/Plavix, Warfarin. Withhold these drugs until after the 30-day follow-up visit.
Avoid enoxaparin at high doses (that is, greater than 30 mg per day) until the subject completes the study.The second page of this PDF shows the medical events being closely monitored for any potential increase in bleeding risk that are the reasons for these exclusions (as they would confound that determination).
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