An observational study in Coronary Disease, sponsored by Italian Society of Invasive Cardiology. Status unknown at 6 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-14.
Sponsored by Italian Society of Invasive Cardiology · Observational
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Among 58 studies in Coronary Disease with a site in Italy — 10 open to participants now, 13 under way, none of them phase 3. Coronary Disease · Italy.
Among the 58 studies in Coronary Disease with a site in Italy, this one is the 6th largest by planned enrollment of the 21 observational ones that give a count, is one of 2 that started in 2018, is one of 21 observational ones, and was the 34th registered.
1,521 studies on the registry are indexed under Coronary Disease; 168 are open to participants now.
Browse Coronary Disease studies →10 of the 58 studies in Coronary Disease with a site in Italy are open now. Recruiting first, the newest first:
Fondazione Ricerca e Innovazione Cardiovascolare ETS · Sites in Italy
Fondazione Don Carlo Gnocchi ETS · Sites in Italy
Ages 18+
Catholic University of the Sacred Heart · Sites in Italy
Ages 40–69 · Healthy volunteers
Robocath · Sites in Italy, Belgium, France and 3 more countries
Ages 18–120
Tampere University · Sites in Italy, Finland, Germany and 3 more countries
Ages 30–80
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 106 Coronary Disease studies recruiting now, 64 (60%) set no upper age limit and 19 (18%) stop at 75 or younger; 8 take children under 18; 10 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
58 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 1,800 is above the median of 916 across 478 observational studies indexed under Coronary Disease.
Median enrollment 476 across the 37 interventional studies, 1,000 across the 21 observational. Of the 34 that completed or were terminated, 12 (35%) have results posted.
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24 of 58 have an industry lead sponsor. The 10 most frequent:
Italian Society of Invasive Cardiology is the lead sponsor of 6 studies on the registry; none are open to participants now.
Italian Society of Invasive Cardiology has 1 study filed under Coronary Disease — fewer than ten, so there is no comparison to draw.
3 of the studies in Coronary Disease with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04433052Tampere UniversityClinical Value and Cost-effectiveness of a Personalized Prevention Program (PPP) in Patients With High Risk Stable CHD | 2026-12 |
| NCT01218776University of BolognaInternational Survey of Acute Coronary Syndromes | 2026-12-31 |
| NCT05027984Centro per la Lotta Contro l'Infarto - Fondazione OnlusInterventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria at OCT in Patients With ACS | 2027-01-31 |
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Among the 58 studies in Coronary Disease with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The MONET registry will include any patient with previous coronary stenting undergoing any type of surgery or operative endoscopic/endovascular procedure. The effects of the application of the Consensus Document "Stent and Surgery-2" on perioperative antiplatelet therapy will be assessed. The study will also assess ischemic and hemorrhagic events in relation to the application of the Consensus Document and length of any antiplatelet discontinuation and delay in performing surgical procedures.
The MONET registry will include any patient with previous coronary stenting undergoing any type of surgery or operative endoscopic/endovascular procedure at the participating Centers. Centers will be divided into two groups: Centers that routinely follow the recommendations of the SAS 2 Document and Centers that do not. The relevant clinical, procedural and outcome data (within index admission and at 30 days) will be entered in a specifically designed electronic case record form (eCRF). The primary endpoint will be the rate of discontinuation of P2Y12 inhibitors and/or aspirin (without bridging) in the first 3 months after PCI with low risk characteristics and 6 months after PCI with high risk characteristics or any antiplatelet therapy discontinuation without bridging therapy. The secondary end-point will be the composite of death, myocardial infarction, probable/definite stent thrombosis and bleeding events at 30 days; the type and the length of discontinuation of any antiplatelet therapy in patients undergoing surgery according to time from PCI to surgery; delay in performing surgical procedure; rate of surgical procedures within 12 months from PCI divided into quartiles (0-3, 3-6, 6-9, 9-12 months).
Patients with prior percutaneous coronary intervention (PCI) with stent implantation undergoing urgent or elective surgical/endoscopic procedures
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Antiplatelet therapy discontinuation in patients with coronary stenting undergoing surgery
Rate of discontinuation of P2Y12 inhibitors and/or aspirin (without bridging) in the first 3 months after PCI with low risk characteristics and 6 months after PCI with high risk characteristics or any antiplatelet therapy discontinuation without bridging therapy
Time frame: 3 months
Antiplatelet therapy discontinuation in patients with coronary stenting undergoing surgery
Rate of discontinuation of P2Y12 inhibitors and/or aspirin (without bridging) in the first 6 months after PCI with high risk characteristics or any antiplatelet therapy discontinuation without bridging therapy
Time frame: 6 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — It is not yet known if there will be a plan to make Individual Participant Data available
Start is estimated for Nov 2018; primary completion for Feb 2019, 3 months later.
Of 132 non-industry observational studies under Coronary Disease, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 192. This study's planned 3 months is below that.
Counting every sponsor, half of 154 studies reached it within 47 months; a quarter within 21 and three quarters within 123.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Italian Society of Invasive Cardiology