Safety of Enoxaparin versus unfractioned heparin in patients undergoing percutaneous coronary intervention using drug eluting stents: A pilot study

Incidence of clinical sign and symptom of acute ischemia and vascular complication with Enoxaparin during stenting in comparison with heparin

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT138710101525N1

Enrollment

200

Registered

2009-12-20

Start date

2004-10-31

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease. Chronic ischaemic heart disease

Interventions

Intervention 1: An intravenous bolus of 10000 IU unfractionated heparin, adjusted for activated clotting time according to current guidelines. Intervention 2: Intravenous Enoxaparin at a dose of 0.75

Prevention

An intravenous bolus of 10000 IU unfractionated heparin, adjusted for activated clotting time according to current guidelines

Intravenous Enoxaparin at a dose of 0.75 mg per kilogram during the procedure

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients with atherosclerotic coronary artery disease (chronic stable angina or acute coronary syndromes) were included if they were candidate for PCI as a result of uncontrolled anginal pain, unresponsive to the maximum dose of nitrates or incidence of adverse drug reactions in which it was impossible to continue medical treatment, Patients with clinical sign of heart failure and ischemic involvement of a relatively large segment of myocardium Exclusion criteria: Age 75 years or older, presence of renal failure defined as creatinine clearance of 30 ml/min and over,creatinine=2.5 mg/dl in male and creatinine=2.0 mg/dl in female participants, use of bare-metal stents, presence of primary PCI, receiving heparin or LMWH before randomization, unacceptable prothrombin time (PT) or platelet count, presence of platelet functional disorders or coagulopathies, or hypercoagulopathy syndromes.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
The incidence of minor bleedings. Timepoint: During the first 24 hours following the index PCI. Method of measurement: by observation.;The incidence of major bleedings. Timepoint: during the first 24 hours following the index PCI. Method of measurement: Major bleeding was defined as clinically overt bleeding causing a decrease in hemoglobin = 3 g/dl requiring transfusion of packed red cells or whole blood, bleedings which require surgical intervention to stop bleeding at the femoral sheath insertion site, intracranial bleeding, and retroperitoneal bleeding.	—

Measure

Time frame

The incidence of minor bleedings. Timepoint: During the first 24 hours following the index PCI. Method of measurement: by observation.;The incidence of major bleedings. Timepoint: during the first 24 hours following the index PCI. Method of measurement: Major bleeding was defined as clinically overt bleeding causing a decrease in hemoglobin = 3 g/dl requiring transfusion of packed red cells or whole blood, bleedings which require surgical intervention to stop bleeding at the femoral sheath insertion site, intracranial bleeding, and retroperitoneal bleeding.

—

Secondary

Measure	Time frame
The incidence of in-stent acute coronary thrombosis. Timepoint: during 24 hours after PCI. Method of measurement: by Observation.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Daneshvar

Cardiovascular Research Center, Shiraz University of Medical Sciences

zdaneshvar@gmail.com

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026