CompletedNot Applicable

ARCANGELO (itAlian pRospective Study on CANGrELOr)

Italy1,005 participantsStarted 2020-10-23

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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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).

What they're measuring

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

Timeframe: 30 days post-PCI

Trial details

NCT IDNCT04471870

SponsorChiesi Farmaceutici S.p.A.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-01-17

View on ClinicalTrials.gov More Acute Coronary Syndrome trials