ARMYDA TICA-MI study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Azienda Ospedaliero-Universitaria Maggiore Della Carita

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Decision date (initial)

2024-08-13

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

University of Eastern Piedmont

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy, Pharmacodynamic

The aim of this study will be to determine whether early administration of oral ticagrelor loading dose, at the initiation of cangrelor infusion, is superior to its late administration (30 minutes before the end of cangrelor infusion) in reducing the incidence of high platelet reactivity (HPR) in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI).

Secondary objectives 1

1. Difference in mean measured closure time, major adverse cardiovascular events (MACE) within 30 days, mortality within 30 days, stent thrombosis within 30 days, unplanned revascularization within 30 days, incidence of peri-procedural infarction, bleeding events according to BARC criteria.

Conditions and MedDRA coding

ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI)

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Diagnosis of ST-elevation myocardial infarction (STEMI) scheduled for primary percutaneous coronary intervention (pPCI); age 18 years or older; informed consent provided; - Clinical indication to administer cangrelor and ticagrelor.

Exclusion criteria 1

1. - Any conditions that, in the opinion of the investigator, contraindicates antiplatelet therapy or would have an unacceptable risk of bleeding. - Clinically significant ongoing bleeding. - Injuries or conditions that significantly increase the risk of major bleeding (these may include recent or ongoing gastric ulceration, presence of cancer with high risk of bleeding, recent brain or spinal trauma, recent brain, spinal or ophthalmic surgery, recent intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular dysfunctions). - Hypersensitivity to the active substance or to any of the excipients. - Known end stage renal disease on hemodialysis. - Known severe hepatic dysfunction. - Acute or severe bronchial asthma or upper airway obstruction. - Current treatment with drugs interfering with CYP3A4 metabolism (to avoid interaction with ticagrelor): Ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromizycin. - Treatment with a P2Y12 receptor antagonist (ticlopidine, clopidogrel, prasugrel, ticagrelor) within 7 days. - Treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban, apixaban, edoxoban) within 7 days. - Known platelet count <100x106/mL. - Known hemoglobin <10 g/dL. - Known hematocrit < 28% - Pregnancy (to be ascertained with pregnancy tests in women of childbearing potential) and breastfeeding. - Inability to provide informed consent.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is the incidence of high platelet reactivity (HPR), defined as a measured closure time (CT) ≤ 106 seconds, at predefined time points after cangrelor interruption, assessed by platelet function analyzer (PFA)-200 P2Y test, in Early Group compared to Delayed Group.

Secondary endpoints 1

1. - Difference in mean measured CT. - Incidence of major adverse cardiovascular events (MACE) within 30 days. - Mortality within 30 days. - Incidence of stent thrombosis within 30 days. - Incidence of unplanned revascularization within 30 days. - Incidence of peri-procedural infarction. - Bleeding events according to the BARC criteria.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Azienda Ospedaliero-Universitaria Maggiore Della Carita

Sponsor organisation

Azienda Ospedaliero-Universitaria Maggiore Della Carita

Address

Corso Giuseppe Mazzini 18

City

Novara

Postcode

28100

Country

Italy

Scientific contact point

Organisation

Azienda Ospedaliero-Universitaria Maggiore Della Carita

Contact name

Giuseppe Patti

Public contact point

Organisation

Azienda Ospedaliero-Universitaria Maggiore Della Carita

Contact name

Giuseppe Patti

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Application history

1 submissions — initial application plus substantial / non-substantial modifications