Acute Coronary SyndromeARCANGELONCT04471870
ARCANGELO (itAlian pRospective Study on CANGrELOr)
An observational study of Acute Coronary Syndrome, run by Chiesi Farmaceutici S.p.A. at 30 sites in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 1,005 participants
- Where
- 30 sitesItaly
- Study dates
- 23 Oct 2020to 17 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute coronary syndromes undergoing percutaneous coronary intervention who receive cangrelor i.v. according to the clinical practice
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
Italy30 sites
A.O.U. Riuniti
Ancona
Ospedale San Donato
Arezzo
A.O.U. Consorziale Policlinico
Bari
Ospedale San Bassiano
Bassano del Grappa
Azienda Ospedaliera San Pio
Benevento
Ospedale Maggiore
Bologna
Fondazione Poliambulanza
Brescia
A.O. Sant'Anna e San Sebastiano
Caserta
A.O.U. Policlinico-Vittorio Emanuele P.O. Ferrarotto
Catania
Ospedale SS Annunziata
Cosenza
ASO Santa Croce e Carle
Cuneo
A.O.U. Careggi
Florence
Ospedale Fabrizio Spaziani
Frosinone
Ospedale S. Andrea
La Spezia
Ospedale Santa Maria Goretti
Latina
Fondazione Toscana "G. Monasterio" Ospedale del Cuore G. Pasquinucci
Massa
Centro Cardiologico Monzino
Milan
A.O.R.N. A. Cardarelli
Naples
A.O.U. Federico II
Naples
A.O. Padova
Padova
Policlinico San Matteo
Pavia
Ospedale degli Infermi
Rivoli
San Camillo Forlanini
Roma, 00152
Aurelia Hospital
Roma
Fondazione Policlinico Universitario A. Gemelli
Roma
A.O.U. Sassari
Sassari
Ospedale Umberto I
Syracuse
A.O. Mauriziano
Torino
Ospedale Santa Chiara
Trento
Ospedale Ca' Foncello
Treviso
About this study
Official title: 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
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).
- Conditions
- Acute Coronary Syndrome
- Keywords
- Real-word, ACS, PCI
- Medical subject headings
- Acute Coronary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of any haemorrages according to BARC (Bleeding Academic Research Consortium) criteria
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.
Measured: 30 days post-PCI
Secondary outcomes (8)
Incidence of type 1-2 (mild) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria
The incidence will be calculated as the ratio between the number of evaluable patients who experience at least one event and the total number of evaluable patients
Measured: 48 hours after PCI
Incidence of type 1-2 (mild) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria
The incidence will be calculated as the ratio between the number of evaluable patients who experience at least one event and the total number of evaluable patientsConsortium [BARC]
Measured: 30 days after PCI
Incidence of type 3-5 (moderate severe) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria
The incidence will be calculated as the ratio between the number of evaluable patients who experience at least one event and the total number of evaluable patientsConsortium [BARC]
Measured: 48 hours after PCI
Incidence of type 3-5 (moderate severe) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria
The incidence will be calculated as the ratio between the number of evaluable patients who experience at least one event and the total number of evaluable patientsConsortium [BARC] bleedings, according to the Bleeding Academic Research Consortium [BARC]
Measured: 30 days after PCI
Incidence of major adverse cardiac events (MACE)
The incidence will be calculated as the ratio between the number of evaluable patients who experience at least one event and the total number of evaluable patients. MACE will comprise any of the following events: death, myocardial infarction (MI), ischemia-driven revascularisation (IDR) and stent thrombosis (ST).
Measured: 48 hours after PCI
Incidence of major adverse cardiac events (MACE)
The incidence will be calculated as the ratio between the number of evaluable patients who experience at least one event and the total number of evaluable patients. MACE will comprise any of the following events: death, myocardial infarction (MI), ischemia-driven revascularisation (IDR) and stent thrombosis (ST).
Measured: 30 days after PCI
To describe the type of oral platelet P2Y12 receptor (prasugrel/ticagrelor/clopidogrel)
It will be calculated the proportion of patients receiving an oral platelet P2Y12 receptor in terms of type (prasugrel/ticagrelor/clopidogrel) and timing of administration
Measured: 30 days after PCI
To describe the use of glycoprotein IIb/IIIa (GPIIb/IIIa) inhibitors
It will be calculated the proportion of patients receiving GPIIb/IIIa inhibitors
Measured: 30 days after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start23 Oct 2020
- Primary completion17 Jan 2022
- Study completion17 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,005 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471870
- Sponsor's protocol ID
- DFIDM-1801
- Other IDs
- EUPAS36393
- Acronym
- ARCANGELO
- Status last verified
- Sep 2026
- First submitted
- 6 Jul 2020
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
De Luca L, Calabro P, Chirillo F, Rolfo C, Menozzi A, Capranzano P, Menichelli M, Nicolini E, Mauro C, Trani C, Versaci F, Tomai F, Musumeci G, Di Mario C, Pepe M, Berti S, Cernetti C, Cirillo P, Maffeo D, Talanas G, Ferlini M, Contarini M, Lanzilotti V, Scherillo M, Tarantini G, Muraglia S, Rossini R, Bolognese L; ARCANGELO study group. Use of cangrelor in patients with acute coronary syndromes undergoing percutaneous coronary intervention: Study design and interim analysis of the ARCANGELO study. Clin Cardiol. 2022 Sep;45(9):913-920. doi: 10.1002/clc.23878. Epub 2022 Jun 22.
PubMed 35733352Capranzano P, Calabro P, Musumeci G, Di Mario C, Nicolini E, Mauro C, Trani C, Versaci F, Tomai F, Pepe M, Berti S, Cernetti C, Cirillo P, De Luca L. Use of cangrelor in patients with reduced renal function: Post-hoc analysis from the ARCANGELO study. Int J Cardiol. 2026 Oct 1;460:134601. doi: 10.1016/j.ijcard.2026.134601. Epub 2026 Jun 3.
PubMed 42242385Capranzano P, Calabro P, Musumeci G, Mario CD, Chirillo F, Rolfo C, Menozzi A, Menichelli M, Maffeo D, Talanas G, Ferlini M, Contarini M, Lanzilotti V, De Luca L. Use of Cangrelor in Older Patients: Findings from the itAlian pRospective Study on CANGrELOr Study. Am J Cardiol. 2025 Apr 1;240:31-37. doi: 10.1016/j.amjcard.2024.12.021. Epub 2024 Dec 21.
PubMed 39716523
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04471870
- Acronym / sponsor ID
- ARCANGELO / DFIDM-1801
- Conditions
- Acute Coronary Syndrome
- Keywords
- Real-word, ACS, PCI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,005 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- 23 Oct 2020 (actual)
- Primary completion
- 17 Jan 2022 (actual)
- Study completion
- 17 Jan 2022 (actual)
- First posted
- 15 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute coronary syndromes undergoing percutaneous coronary intervention who receive cangrelor i.v. according to the clinical practice
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
8 secondary outcomes
Incidence of type 1-2 (mild) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria
Time frame: 48 hours after PCI
Incidence of type 1-2 (mild) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria
Time frame: 30 days after PCI
Incidence of type 3-5 (moderate severe) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria
Time frame: 48 hours after PCI
Incidence of type 3-5 (moderate severe) bleedings, according to the Bleeding Academic Research Consortium [BARC] criteria
Time frame: 30 days after PCI
Incidence of major adverse cardiac events (MACE)
Time frame: 48 hours after PCI
Incidence of major adverse cardiac events (MACE)
Time frame: 30 days after PCI
To describe the type of oral platelet P2Y12 receptor (prasugrel/ticagrelor/clopidogrel)
Time frame: 30 days after PCI
To describe the use of glycoprotein IIb/IIIa (GPIIb/IIIa) inhibitors
Time frame: 30 days after PCI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Results publication: PubMed 35733352De Luca L, Calabro P, Chirillo F, Rolfo C, Menozzi A, Capranzano P, Menichelli M, Nicolini E, Mauro C, Trani C, Versaci F, Tomai F, Musumeci G, Di Mario C, Pepe M, Berti S, Cernetti C, Cirillo P, Maffeo D, Talanas G, Ferlini M, Contarini M, Lanzilotti V, Scherillo M, Tarantini G, Muraglia S, Rossini R, Bolognese L; ARCANGELO study group. Use of cangrelor in patients with acute coronary syndromes undergoing percutaneous coronary intervention: Study design and interim analysis of the ARCANGELO study. Clin Cardiol. 2022 Sep;45(9):913-920. doi: 10.1002/clc.23878. Epub 2022 Jun 22.
- Results publication: PubMed 42242385Capranzano P, Calabro P, Musumeci G, Di Mario C, Nicolini E, Mauro C, Trani C, Versaci F, Tomai F, Pepe M, Berti S, Cernetti C, Cirillo P, De Luca L. Use of cangrelor in patients with reduced renal function: Post-hoc analysis from the ARCANGELO study. Int J Cardiol. 2026 Oct 1;460:134601. doi: 10.1016/j.ijcard.2026.134601. Epub 2026 Jun 3.
- Derived from this study: PubMed 39716523Capranzano P, Calabro P, Musumeci G, Mario CD, Chirillo F, Rolfo C, Menozzi A, Menichelli M, Maffeo D, Talanas G, Ferlini M, Contarini M, Lanzilotti V, De Luca L. Use of Cangrelor in Older Patients: Findings from the itAlian pRospective Study on CANGrELOr Study. Am J Cardiol. 2025 Apr 1;240:31-37. doi: 10.1016/j.amjcard.2024.12.021. Epub 2024 Dec 21.
- Individual participant dataSharing planned: No
Related trials for Acute Coronary Syndrome
Not yet recruitingObservational study
Prognostic Value of Functional-Nutritional Status in Older Adults With Acute Coronary Syndrome
Acute Coronary Syndromes (ACS)
RecruitingPhase 4
Early Initiation of Tafolecimab for Patients With Acute Coronary Syndromeundergoing Percutaneous Coronary Intervention in Chinese Population
Acute Coronary Syndrome, Non ST Segment Elevation Acute Coronary Syndrome
Active, not recruiting
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo Lesions
Coronary Artery Disease, Atherosclerosis of Coronary Artery
Active, not recruiting
Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria at OCT in Patients With ACS
Coronary Artery Disease, Coronary Disease
Enrolling by invitationObservational study
Prevalence of CYP2C19 Genetic Polymorphisms Among Egyptian Patients Receiving Clopidogrel Following PCI
Acute Coronary Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by Chiesi Farmaceutici S.p.A. at 30 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of any haemorrages according to BARC (Bleeding Academic Research Consortium) criteria (time frame: 30 days post-PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04471870, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.