Status:
COMPLETED
ARCANGELO (itAlian pRospective Study on CANGrELOr)
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
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 pra...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 23 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 17 2022
Estimated Enrollment :
1005 Patients enrolled
Trial Details
Trial ID
NCT04471870
Start Date
October 23 2020
End Date
January 17 2022
Last Update
March 9 2022
Active Locations (30)
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1
A.O.U. Riuniti
Ancona, Italy
2
Ospedale San Donato
Arezzo, Italy
3
A.O.U. Consorziale Policlinico
Bari, Italy
4
Ospedale San Bassiano
Bassano del Grappa, Italy