A Phase 4 interventional study of Low-dose heparin and Standard dose heparin in Stable Angina, Angina, Unstable and Non-ST Elevation (NSTEMI) Myocardial Infarction, sponsored by San Filippo Neri General Hospital. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-09-27.
Sponsored by San Filippo Neri General Hospital · Phase 4, Interventional, and Treatment
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Among 23 studies in Angina, Stable with a site in Italy — 3 open to participants now, 4 under way, none of them phase 3. Angina, Stable · Italy.
Among the 23 studies in Angina, Stable with a site in Italy, this one is the 4th largest by planned enrollment of the 17 interventional ones that give a count, is one of 2 that started in 2010, is one of 4 in phase 4, and was the 10th registered.
343 studies on the registry are indexed under Angina, Stable; 56 are open to participants now.
Browse Angina, Stable studies →3 of the 23 studies in Angina, Stable with a site in Italy are open now. Recruiting first, the newest first:
IRCCS Ospedale San Raffaele · Sites in Italy
Ages 18+
Catholic University of the Sacred Heart · Sites in Italy
Ages 18+
GE Healthcare · Sites in Italy
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 39 Angina, Stable studies recruiting now, 33 (85%) set no upper age limit and 2 (5%) stop at 75 or younger; 2 take children under 18; 1 takes 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.
23 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 2 started in 2010.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 1,000 is above the median of 150 across 230 interventional studies indexed under Angina, Stable.
Median enrollment 323 across the 17 interventional studies, 600 across the 6 observational. Of the 11 that completed or were terminated, 1 (9%) have results posted.
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9 of 23 have an industry lead sponsor. The 10 most frequent:
San Filippo Neri General Hospital is the lead sponsor of 10 studies on the registry; none are open to participants now.
San Filippo Neri General Hospital has 3 studies filed under Angina, Stable — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 23 studies in Angina, Stable with a site in Italy, from their registry updates:
Nothing recorded among them since 2026-09-25.
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International guidelines support the use of a full-dose heparin (anticoagulants) during coronary intervention. However, a lower dose of heparin may be adequate, thanks to advances in angioplasty techniques and the widespread use of pretreatment with two antiplatelet agents.
Thus the investigators designed a study comparing safety and efficacy of standard dose heparin (100 UI/Kg) versus low-dose (50 UI/Kg) in patients undergoing coronary angioplasty who are on aspirin and clopidogrel at the time of the procedure.
Aim of the study is to show equivalence in ischemic events between the two doses of heparin, in order to confirm the safety of lower dose of heparin in contemporary coronary interventions.
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:
Bolus of 100 UI/Kg of heparin. Activated clotting time (ACT) \> 300 sec. during the procedure
Drug: Standard dose heparin
Bolus of 50 UI/Kg heparin with a target ACT during the procedure of \>200 sec.
Drug: Low-dose heparin
Bolus of 50 UI/Kg of heparin at the beginning of coronary interventions
Also known as: 50 UI/Kg bolus heparin
Bolus of 100 UI/Kg of heparin at the beginning of coronary interventional procedure.
Also known as: 100 Ui/Kg bolus heparin
MACE + stent thrombosis + major bleeding (TIMI definition)
MACE (death, myocardial infarction, target vessel revascularization) + stent thrombosis + major bleeding (TIMI definition)
Time frame: 30 days
MACE
MACE = death, myocardial infarction, target vessel revascularization
Time frame: 30 days
Major Bleeding
Major bleeding according to TIMI criteria
Time frame: 30 days
Stent thrombosis
Stent thrombosis (definite or probable according to ARC criteria)
Time frame: 30 days
CK-MB increase
Any CK MB increase \>3 times upper limit of normal or \>50% baseline levels (if baseline levels already \>then upper limit of normal)
Time frame: 30 days
Major bleeding
Major bleeding according to STEEPLE criteria
Time frame: 30 days
The record gives a start of Jan 2010, a primary completion of Dec 2012 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Heparin
San Filippo Neri General Hospital