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Clinical Trials/NCT04471870
NCT04471870
Completed
Not Applicable

Multicentre Observational, Prospective Cohort Study Including Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention Who Receive Cangrelor i.v. Transitioning to Clopidogrel, Prasugrel or Ticagrelor Per os

Chiesi Farmaceutici S.p.A.30 sites in 1 country1,005 target enrollmentStarted: October 23, 2020Last updated:
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ConditionsAcute Coronary Syndrome

Overview

Phase
Not Applicable
Status
Completed
Enrollment
1,005
Locations
30
Primary Endpoint
Incidence of any haemorrages according to BARC (Bleeding Academic Research Consortium) criteria
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The Sponsor implemented a post-authorisation safety study (PASS), category 3, focused in Acute Coronary Syndrome, in order to collect information about the safety of cangrelor in the real clinical practice, evaluating the safety of the transition to all the oral P2Y12 inhibitors (cangrelor, ticagrelor and prasugrel).

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients' written informed and privacy consent obtained before or at the end of the PCI procedure according to patients' condition but in any case, prior to collection of any study-related data;
  • •Male or female patients aged ≥ 18 years;
  • •Patients with acute coronary syndromes undergoing PCI;
  • •Patients who are planned to be treated with cangrelor, or who have received treatment with cangrelor.

Exclusion Criteria

  • •Patients with active bleeding or increased risk of bleeding, because of impaired haemostasis and/or irreversible coagulation disorders or due to recent major surgery/trauma or uncontrolled severe hypertension;
  • •Patients with history of stroke or transient ischaemic attack (TIA);
  • •Patients with hypersensitivity to the active substance (cangrelor) or to any of its excipients;
  • •Known pregnancy or breast-feeding female patients;
  • •Patients with stable angina (SA).

Outcomes

Primary Outcomes

Incidence of any haemorrages according to BARC (Bleeding Academic Research Consortium) criteria

Time Frame: 30 days post-PCI

The incidence will be calculated as the ratio between the number of patients experiencing at least one event during the 30-day observation period over the total number of evaluable patients.

Secondary Outcomes

  • Incidence of type 1-2 (mild) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria(30 days after PCI)
  • Incidence of type 3-5 (moderate severe) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria(30 days after PCI)
  • Incidence of major adverse cardiac events (MACE)(30 days after PCI)
  • To describe the type of oral platelet P2Y12 receptor (prasugrel/ticagrelor/clopidogrel)(30 days after PCI)
  • To describe the use of glycoprotein IIb/IIIa (GPIIb/IIIa) inhibitors(30 days after PCI)
  • Incidence of type 1-2 (mild) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria(48 hours after PCI)
  • Incidence of type 3-5 (moderate severe) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria(48 hours after PCI)
  • Incidence of major adverse cardiac events (MACE)(48 hours after PCI)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (30)

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