NCT03772613

Brief Summary

The purpose of this study is to find the ideal range of the activated clotting time (ACT) during percutaneous coronary intervention (PCI) that is associated with lowering the rate of undesirable medical outcomes

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for phase_2 coronary-artery-disease

Timeline
Completed

Started Feb 2019

Typical duration for phase_2 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 11, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

February 8, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2021

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

April 4, 2023

Completed
Last Updated

April 4, 2023

Status Verified

March 1, 2023

Enrollment Period

2.7 years

First QC Date

December 8, 2018

Results QC Date

March 8, 2023

Last Update Submit

March 8, 2023

Conditions

Coronary Artery DiseaseIschemic Heart DiseaseAnticoagulant-induced BleedingCoronary Syndrome

Keywords

activated clotting timeoutcomesbleeding

Outcome Measures

Primary Outcomes (2)

  • Bleeding

    Number of subjects to experience bleeding defined as Bleeding Academic Research Consortium (BARC) 1, 2, 3 or 5 or EASY hematoma classification after transradial/ulnar procedures (I-V)

    From date of randomization until the date of first documented bleeding event up to 24 hours

  • Adverse Clinical Events

    Number of subjects to experience a Net Adverse Clinical Event (NACE) defined as all-cause mortality, myocardial infarction, stroke, target lesion revascularization, or major bleeding

    30 days

Secondary Outcomes (1)

  • Stent Thrombosis

    30 days

Study Arms (3)

Low ACT Target

ACTIVE COMPARATOR

ACT target range of 225 to 275 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used

Drug: Unfractionated heparin

Medium ACT Target

ACTIVE COMPARATOR

ACT target range of 275 to 325 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used

Drug: Unfractionated heparin

High ACT Target

ACTIVE COMPARATOR

ACT target range of 325 to 375 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used

Drug: Unfractionated heparin

Interventions

Unfractionated heparinDRUG

Administration of unfractionated heparin will be assessed using the activated clotting time

High ACT TargetLow ACT TargetMedium ACT Target

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age\>18
  • Referred for coronary angiography with possible coronary revascularization or adjunctive invasive diagnostic testing (IVUS/OCT, FFR, or iFR)

You may not qualify if:

  • Receipt of LMWH at treatment dose (not DVT prophylaxis dose) within 6 hours of coronary angiography
  • Prior GP IIb/IIIa use within the previous 72 hours
  • Use of warfarin (vitamin K antagonist) or direct oral anticoagulant
  • Patients on LMWH bridging strategy
  • PCI within prior 30 days
  • Planned use of bivalirudin as the procedural anticoagulant
  • Rotational atherectomy
  • Excimer laser coronary angioplasty
  • Chronic total occlusions
  • Patients with active bleeding disorders or bleeding diathesis
  • Patients with ST-segment elevation myocardial infarction
  • Patient with clinical evidence of cardiogenic shock (defined as SBP\<90 mmHg for ≥30 min OR support to maintain SBP ≥90 mmHg AND evidence of end-organ hypoperfusion (urine output \<30 mL/h or cool extremities)
  • Chronic kidney disease stage 4/5 (GFR 30 mL/min)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial IschemiaAngina, UnstableHemorrhage

Interventions

Heparin

Condition Hierarchy (Ancestors)

Coronary DiseaseHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesAngina PectorisChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Results Point of Contact

Title
Dr. Shahyar M. Gharacholou
Organization
Mayo Clinic
Gharacholou.Shahyar@mayo.edu
904-956-8400

Study Officials

  • Shahyar M Gharacholou, MD, MSc

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 8, 2018

First Posted

December 11, 2018

Study Start

February 8, 2019

Primary Completion

October 25, 2021

Study Completion

October 25, 2021

Last Updated

April 4, 2023

Results First Posted

April 4, 2023

Record last verified: 2023-03

Locations

US(1)