Clinical Study Report - Calidad de Información CFR

2) Heparin
- Heparin bolus administration prior to PCI procedure
If the activated clotting time (ACT) of a subject prior to the PCI procedure is below
200 seconds, heparin bolus is administrated to the artery access site according to
the following regimen:
ACT < 150 seconds: administer 70 U/㎏heparin
ACT = 150 to 199 seconds: administer 50 U/㎏heparin
ACT ≥ 200 seconds: administer no heparin
- Additional heparin bolus administration during PCI procedure
If the ACT is below 200 seconds, additional 20 U/kg heparin bolus is given to
achieve and maintain an ACT of > 200 seconds during the procedure. If the ACT is
still below 200 seconds, additional 20 U/kg heparin bolus is given until the ACT
reaches longer than 200 seconds.
- Heparin injection after the PCI procedure is performed at the investigator’s discretion.
(3) The investigator recorded all concomitant treatments on CRF including antihypertensive
drug (for example, Nitrates, β-adrenergic receptor blocker, Ca channel blocker, ACE inhibitor
etc.). This record included the name of drugs, daily total dose, route of administration , onset
and stop date of administration, and the indication.
9.4.5.2. Restrictions on concomitant medication
Following medications may have an effect on the trial, and were prohibited during the trial
period.
- Oral anticoagulants
- Dextran (Concomitant use of dextran intravenously prior to PCI or during PCI was
contraindicatd.)
9.5. Efficacy and safety variables
Efficacy endpoints
(1) Primary efficacy endpoint
CSR_Clotinab_II 30
Ver. 1.0_Eng