Phase 3
N=200
(A Novel Pharmacologic Regime for Elective Percutaneous Coronary Intervention)
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT01031095 ↗Enrolled (actual)
200
Serious AEs
1.5%
Results posted
Oct 2013
Primary outcome: Primary: Major Adverse Cardiac Events — 2 percentage of event
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- coronary intervention (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bursa Postgraduate Hospital
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Major Adverse Cardiac Events |
2 | — |
| PRIMARY Major Adverse Cardiac Event |
1 | — |
Summary
The hypothesis:
Low dose intracoronary unfractionated heparin is as effective and safe as standard dose intravenous unfractionated heparin on patients with elective percutaneous coronary intervention.
Eligibility Criteria
Inclusion Criteria
- The patients; who have planned elective PCI and have had written informed consent for participation to study.
- The native coronary artery;
- lesion with narrowing >=70%,
- lesion without thrombus
- no left main coronary artery (LMCA) lesion
- no chronic total occlusion lesion
Exclusion Criteria
- Patients have allergy for acetylsalicylic acid (ASA), Clopidogrel and heparin
- Patients who performed primary PCI
- Patients with acute coronary syndrome
- Patients with have a history of myocardial infarction (MI) for two weeks
- Patients who were use UFH or low molecular weight heparin (LMWH) for 24 hours
- Patients on warfarin therapy
- Patients who have bleeding diathesis, or have high risk for bleeding.
Data sourced from ClinicalTrials.gov (NCT01031095). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.