E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
With the novel oral anticoagulants, including EDOXABAN-DABIGATRANRIVAROXABAN-
APIXABAN, we are entering a new era of anticoagulation
for atrial fibrillation (AF) (and deep vein thrombosis).
Nevertheless, at the time, the lack of a reversal agent is an important
limitation with these agents, especially in case of major hemorrhage or
the need to perform emergency invasive procedures. |
|
E.1.1.1 | Medical condition in easily understood language |
Reversal of anticoagulation by drugs |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10060319 |
E.1.2 | Term | Anticoagulation drug level therapeutic |
E.1.2 | System Organ Class | 10022891 - Investigations |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this trial addresses the potential of intravenous
protamine to reverse the anticoagulant effect of heparin and:
Obtain improved local haemostasis after radial arterial sheet (5french)
removal in stable cardiac patients undergoing a diagnostic coronary
angiogram ('bleeding time'). |
|
E.2.2 | Secondary objectives of the trial |
Measurements of standard laboratory markers of anticoagulation will be
used as evidence of reversal |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subject is eligible for diagnostic angiography via radial route for
suspected coronary artery disease ('stable patients & lesions'). |
|
E.4 | Principal exclusion criteria |
1) An unfavourable angiographic morphology:
a. Left main coronary artery stenosis >50% by visual estimate.
b. Angiographic flow limiting complication (including visible
thrombus)
2) Pre-treatement with a P2Y12 receptor blocker.
3) A known coagulopathy or bleeding diathesis |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy end point is the time to hemostasis at the radial
artery puncture site after arterial sheath removal (dichotomized per 15
minutes). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
4 timepoints 15-30-60 minutes and 6 hours post randomization |
|
E.5.2 | Secondary end point(s) |
Laboratory evidence of reversal of systemic anticoagulation expressed
by measurements of standard laboratory markers [6* (2*4,5ml)= 54ml
citrated blood]. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
4 timepoints 15-30-60 minutes and 6 hours post randomization |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
12 hours after the randomization of the last patient
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |