The Prognostic Value of ADP-Induced Platelet Aggregation for Bleeding Complications in Low – Intermediate Risk Patients with Acute Coronary Syndrome Taking Clopidogrel After Percutaneous Coronary Intervention

Jin, Lina; Hou, Yu; Dong, Tingting; Zhou, Bin; Yan, Hong; Liao, Hongtao; Zou, Xia

doi:10.1016/j.hlc.2016.05.113

Cited by 8 publications

(4 citation statements)

References 28 publications

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“…The safety profile of the generic Ticaloguard ® was comparable with its brand Brilique®. Several clinical studies have correlated platelet inhibition with bleeding risk [ 39 , 40 ]. In the present study, no bleeding events were recorded in both generic and brand ticagrelor.…”

Section: Discussionmentioning

confidence: 99%

Testing P2Y12 platelet inhibitors generics beyond bioequivalence: a parallel single-blinded randomized trial

et al. 2022

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Cardiovascular diseases are the leading cause of death worldwide. Ticagrelor is an oral antiplatelet drug used in acute coronary syndrome. Although generic drugs are approved for their bioequivalence to the original product, they are not necessarily to be therapeutically equivalent. This study was conducted to prove the efficacy and safety of ticagrelor generically named Ticaloguard® compared to its brand Brilique® in healthy volunteers. A loading dose of 180 mg ticagrelor named Brilique® or Ticaloguard® followed by a 90 mg twice daily regimen as maintenance dose was given to 14 and 15 volunteers in Tica and Brili groups, respectively. The platelet aggregation on the ADP agonist was assessed at baseline and repeated 1 h and 3 h after the loading dose, on day 4 (after reaching steady-state), 12 and 24 h after discontinuation of the antiplatelet drug. Adverse effects from trial medications were noted by direct questions. It was shown that generic Ticaloguard® provides a similar therapeutic effect and safety as its branded Brilique® (p > 0.05). This will permit safe and trusted use of the generic Ticaloguard® when treating it in the same manner as Brilique®. Testing generic drug effects rather than simple bioequivalency, especially for drugs that are used in critical life-threatening situations, is crucial. We advocate applying this form of a clinical trial to test surrogate clinical efficacy for generics used in critical indications before having real-world data whenever possible.

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Section: Discussionmentioning

confidence: 99%

Testing P2Y12 platelet inhibitors generics beyond bioequivalence: a parallel single-blinded randomized trial

et al. 2022

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“…2 ). The decrease in aggregation rate measured by light transmittance aggregometry correlates with the amount of bleeding 26 , 27 . P-selectin (CD62P) is a membrane protein present in α granules of platelets, and its expression level on the unstimulated platelet surface is a common measure of platelet activations 28 .…”

Section: Discussionmentioning

confidence: 99%

Effects of whole blood storage in a polyolefin blood bag on platelets for acute normovolemic hemodilution

Murata

Kusudo

Kawamoto

et al. 2021

Sci Rep

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Acute normovolemic hemodilution (ANH) is a potential transfusion method for platelets, as well as for red blood cells. However, previous studies have shown that whole blood storage in ANH decreases platelet aggregability by 14.7–76.3% and that this decrease is not recovered by reinfusion. We investigated whether a new whole blood storage method for 6 h using a polyolefin bag, based on the platelet concentrates storage method, would maintain platelet function better than the conventional method using a polyvinyl chloride bag. We demonstrated that storage of whole blood in a polyolefin bag maintained ADP-induced aggregation rates at more than twofold higher than those in a polyvinyl chloride bag, and also significantly suppressed P-selectin expression, a platelet activation marker (ADP-induced aggregation rates: 24.6 ± 5.1% vs. 51.7 ± 11.5%, p = 0.002; P-selectin expression; 50.3 ± 8.4MFI vs. 31.6 ± 9.3MFI, p = 0.018). These results could be attributed to the high gas permeability of polyolefin, which lowered PCO2 and maintained a high pH with or without agitation. There were no significant changes in platelet count and red blood cell parameters due to the storage methods. Our results suggest that ANH using polyolefin bags is advantageous in improving hemostatic function compared to the conventional method.

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“…Several clinical studies that have used the same assays have correlated platelet inhibition with bleeding risk. [34][35][36] In a literature review and expert consensus statement and in a large meta-analysis of 17 clinical trials that included more than 20,000 patients who were undergoing percutaneous coronary intervention and whose platelet function was measured with the use of a point-of-care P2Y 12 platelet-reactivity test or a VASP assay, low platelet reactivity was independently associated with an elevated bleeding risk. 37,38 In this trial involving volunteers who were pretreated with ticagrelor, low platelet reactivity was rapidly reversed by a new targeted monoclonal antibody fragment.…”

Section: Discussionmentioning

confidence: 99%

Antibody-Based Ticagrelor Reversal Agent in Healthy Volunteers

2019

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The Prognostic Value of ADP-Induced Platelet Aggregation for Bleeding Complications in Low – Intermediate Risk Patients with Acute Coronary Syndrome Taking Clopidogrel After Percutaneous Coronary Intervention

Cited by 8 publications

References 28 publications

Testing P2Y12 platelet inhibitors generics beyond bioequivalence: a parallel single-blinded randomized trial

Testing P2Y12 platelet inhibitors generics beyond bioequivalence: a parallel single-blinded randomized trial

Effects of whole blood storage in a polyolefin blood bag on platelets for acute normovolemic hemodilution

Antibody-Based Ticagrelor Reversal Agent in Healthy Volunteers

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