An observational study in Acute Myocardial Infarction, Unstable Angina and Chronic Stable Angina, sponsored by Italian Society of Invasive Cardiology. Status unknown at 10 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-22.
Sponsored by Italian Society of Invasive Cardiology · Observational
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Among 34 studies in Angina, Unstable with a site in Italy — 7 open to participants now, 9 under way, none of them phase 3. Angina, Unstable · Italy.
Among the 34 studies in Angina, Unstable with a site in Italy, this one is the 7th largest by planned enrollment of the 16 observational ones that give a count, is one of 2 that started in 2018, is one of 17 observational ones, and was the 23rd registered.
328 studies on the registry are indexed under Angina, Unstable; 42 are open to participants now.
Browse Angina, Unstable studies →7 of the 34 studies in Angina, Unstable with a site in Italy are open now. Recruiting first, the newest first:
Humanitas Hospital, Italy · Sites in Italy
Ages 18+ · Healthy volunteers
Niguarda Hospital · Sites in Italy
Ages 18–75
Istituto Nazionale di Ricovero e Cura per Anziani · Sites in Italy
Ages 18+
IRCCS Policlinico S. Donato · Sites in Italy
Ages 18+
Catholic University of the Sacred Heart · Sites in Italy
Ages 18+
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 34 Angina, Unstable studies recruiting now, 29 (85%) set no upper age limit and 3 (9%) stop at 75 or younger; 3 take children under 18; 3 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.
34 studies; the count open now beside each. This study's row is marked.
First in 2005; 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 1,080 is close to the median of 982 across 121 observational studies indexed under Angina, Unstable.
Median enrollment 996 across the 17 interventional studies, 1,000 across the 16 observational. Of the 13 that completed or were terminated, 3 (23%) have results posted.
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9 of 34 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 2 studies filed under Angina, Unstable — fewer than ten, so there is no comparison to draw.
2 of the studies in Angina, Unstable 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 |
|---|---|
| NCT01218776University of BolognaInternational Survey of Acute Coronary Syndromes | 2026-12-31 |
| NCT06313645Niguarda HospitalVascular Senescence and Atherosclerotic Plaque Vulnerability | 2027-07-01 |
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Among the 34 studies in Angina, Unstable with a site in Italy, from their registry updates:
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Approximately 5 to 8% of patients undergoing percutaneous coronary interventions requires chronic anticoagulant therapy due to atrial fibrillation or other clinical entities. There are many possible different combinations of the antithrombotic therapy after stent implantation in these patients.
Aim of this observational study is to evaluate the real world antithrombotic treatment in patients requiring anticoagulant therapy undergoing stent implantation and to compare the clinical outcome of patients treated with new oral anticoagulant drugs compared to warfarin.
The study is prospective, performed in different Italian hospitals and aimed to enroll 1080 patients with a 1 year follow up
Approximately 5 to 8% of patients undergoing percutaneous coronary interventions requires chronic anticoagulant therapy due to atrial fibrillation or other clinical entities. These patients pose particular problems when undergo percutaneous coronary intervention with stent implantation (PCI-S), because of the different antithrombotic and oral anticoagulant (OAC) strategies required after the procedure when dual antiplatelet therapy is recommended. Consequently, this scenario requires careful consideration balancing bleeding, stroke and acute coronary syndrome risks.
New oral anticoagulants (NOAC) have been compared to warfarin for stroke prevention in the setting of atrial fibrillation and all these drugs showed a similar or improved efficacy over warfarin in term of ischemic events as well as bleeding complications reduction. In particular, an important safety issue is the reduction of intracranial bleeding compared to warfarin. Currently, four different NOAC have been approved for the treatment of patients with atrial fibrillation: apixaban, edoxaban, rivaroxaban and dabigatran. The first three drugs are anti Xa inhibitors whereas the last one is a direct thrombin inhibitor.
Data regarding the combination of NOAC and antiplatelet therapy after PCI-S in patients requiring chronic anticoagulant therapy are currently scarce.
The aim of our study is to perform a prospective, multicenter, observational, controlled study on patients requiring chronic anticoagulant treatment with either vitamin K antagonists or NOAC undergoing PCI-S for concomitant coronary disease.
The primary objectives of the study are:
According to the observational design of the study, anticoagulant therapy (vitamin antagonists or new oral anticoagulant drugs), other pharmacological therapy as well as procedural device utilized, before, during the procedure and at follow-up will be left to the physician decision.
The events will be adjudicated by a clinical event committee (CEC) comprised of qualified physicians. The CEC is responsible for adjudicating all potential endpoint events, including death, bleeding, myocardial infarction, stent thrombosis, stroke, and coronary revascularization
Patients with chronic disease requiring oral anticoagulant therapy (atrial fibrillation, prosthetic valves, previous pulmonary embolism, venous thrombosis) undergoing either elective, urgent or emergency percutaneous coronary interventions with stent implantation for acute or chronic coronary disease.
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.
Net Adverse Clinical Event
major bleeding, myocardial infarction, death, stroke, myocardial revascularization
Time frame: 1 year
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
Ran from Feb 2018 to primary completion in Feb 2022, 48 months.
Of 51 non-industry observational studies under Angina, Unstable, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 86. This study's 48 months is close to that.
Counting every sponsor, half of 62 studies reached it within 38 months; a quarter within 19 and three quarters within 71.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Italian Society of Invasive Cardiology