Maintenance of Platelet Inhibition With Cangrelor

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• Acute Coronary Syndrome 1,461

Acute Coronary Syndrome

1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.

This study's enrollment of 221 is above the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.

Lead sponsor

The Medicines Company is the lead sponsor of 48 studies on the registry; none are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 7 (88%) have results posted.

Study arms

• Experimental
  Cangrelor

  Cangrelor was administered as a continuous IV infusion of 0.75µg/kg/min for a minimum of 48 hours and a maximum of 7 days.

  Drug: cangrelor

• Placebo comparator
  Placebo

  A placebo infusion was administered as a continuous IV infusion of 0.75µg/kg/min for a minimum of 48 hours and a maximum of 7 days, to maintain the blind.

  Other: Placebo

Interventions

• Drugcangrelor
• OtherPlacebo

  Placebo IV infusion administered in the same fashion as the active study drug in order to maintain the blind in the study.

Primary outcomes

1. Stage I: Percentage of Patient Samples That Maintained Platelet Inhibition Levels of Greater Than or Equal to 60% as Reported by the VerifyNow P2Y12 Point of Care Assay.

   Endpoint was selected as an approximation of the antiplatelet effect expected to be maintained if oral P2Y12 inhibitors had not been discontinued (60% inhibition of platelets).

   Time frame: During study drug infusion up to 1-6 hours prior to surgery

2. Stage II: The Percentage of Patients That Maintained Platelet Reaction Units (PRU) < 240, as Determined by the VerifyNow P2Y12 Point of Care Assay, Measured During Study Drug Infusion Pre-surgery.

   This endpoint was selected as it is considered by consensus of the Working Group on Platelet Reactivity to be the threshold for the level of platelet inhibition required to maintain a low risk of coronary thrombosis and cardiac ischemic events. Patients had multiple samples and all "on-infusion" samples had to be \<240 PRU to meet the endpoint.

   Time frame: During study drug infusion up to 1-6 hours prior to surgery

Secondary outcomes

1. Stage II: Analysis of Platelet Reactivity (ITT Population) / Patients With Platelet Reactivity < 240 PRU

   This endpoint analyzed the percent of patients with platelet reactivity \< 240 PRU at the following timepoints: * Baseline - Prior to study drug infusion (washout period from oral P2Y12 inhibition) * Last sample during infusion * Following discontinuation of study drug infusion

   Time frame: baseline until just prior to surgery (post infusion)

2. Incidence of Excessive Coronary Artery Bypass Graft (CABG)-Related Bleeding

   Defined as the occurrence of surgical re-exploration, 24-hour chest tube output of \>1.5 liters (L), and/or packed red blood cell transfusions \> 4 units

   Time frame: Randomization through Hospital discharge

3. Non-CABG (Preoperative) Bleeding - Protocol-defined GUSTO Severe/Life-threatening, Moderate and Mild

   Time frame: Randomization until start of CABG surgery

4. Patients With Blood Product Transfusions up to 7 Days After Surgery or Discharge, Whichever Was Sooner

   Time frame: Through 7 days or hospital discharge, whichever was sooner

Baseline characteristics

Publications

• Angiolillo DJ, Firstenberg MS, Price MJ, Tummala PE, Hutyra M, Welsby IJ, Voeltz MD, Chandna H, Ramaiah C, Brtko M, Cannon L, Dyke C, Liu T, Montalescot G, Manoukian SV, Prats J, Topol EJ; BRIDGE Investigators. Bridging antiplatelet therapy with cangrelor in patients undergoing cardiac surgery: a randomized controlled trial. JAMA. 2012 Jan 18;307(3):265-74. doi: 10.1001/jama.2011.2002. PubMed 22253393 ↗