(A Novel Pharmacologic Regime for Elective Percutaneous Coronary Intervention)

NCT01031095 | Completed Phase 3 Results

• 1 other identifier: BYİEAH1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Keywords

percutaneous coronary intervention; low dose intracoronary heparin

Outcome Measures

Primary Outcomes (2)

• Major Adverse Cardiac Events

  30 days

• Major Adverse Cardiac Event

  30 days

Study Arms (2)

Low dose intracoronary heparin

EXPERIMENTAL

Low dose intracoronary heparin: In this group elective coronary intervention was performed with low dose intracoronary Heparin

Other: coronary intervention

Standard treatment arm

ACTIVE COMPARATOR

Standard treatment arm: In this group elective coronary intervention performed with standard dose intravenous heparin

Other: coronary intervention

Interventions

coronary intervention OTHER

elective coronary intervention

Low dose intracoronary heparin; Standard treatment arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bursa Postgraduate Hospital: lead

Study Sites (1)

Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi

Bursa, 16320, Turkey (Türkiye)

Location

Related Publications (2)

• Stabile E, Nammas W, Salemme L, Sorropago G, Cioppa A, Tesorio T, Ambrosini V, Campopiano E, Popusoi G, Biondi Zoccai G, Rubino P. The CIAO (Coronary Interventions Antiplatelet-based Only) Study: a randomized study comparing standard anticoagulation regimen to absence of anticoagulation for elective percutaneous coronary intervention. J Am Coll Cardiol. 2008 Oct 14;52(16):1293-8. doi: 10.1016/j.jacc.2008.07.026.

  PMID: 18929239 BACKGROUND

• Ari H, Kivac E, Ari S, Emlek N, Cetinkaya S, Celiloglu N, Sarigul OY, Aydin C, Akkaya M, Koca V, Bozat T, Gurdogan M. The REDUCED (a RandomisED stUdy Comparing standard systemic anticoagulation thErapy to low Dose intracoronary anticoagulation therapy for elective percutaneous coronary intervention) trial. A novel pharmacologic regime for elective percutaneous coronary intervention. Acta Cardiol. 2014 Dec;69(6):619-27. doi: 10.1080/ac.69.6.1000004.

  PMID: 25643432 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Limitations and Caveats

The intraprocedural use of a heparinised flush was not controlled; however, given the maximum amount that was allowed to be used, this is not likely to have significantly affected the activated clotting times. .

Results Point of Contact

• Title: Dr.Hasan ARI
• Organization: Bursa Postgraduate Hospital

hasanari03@yahoo.com

00902243605050

Study Officials

• Hasan Arı, MD

  Bursa Postgraduate Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Bursa Postgraduate Hospital

Study Record Dates

• First Submitted: December 11, 2009
• First Posted: December 14, 2009
• Study Start: June 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: June 1, 2010
• Last Updated: January 30, 2014
• Results First Posted: October 10, 2013

Record last verified: 2013-12

Locations

TU (1)