Trial · NCT01347580

A 30 Day Study to Evaluate Efficacy and Safety of Pre-hospital vs. In-hospital Initiation of Ticagrelor Therapy in STEMI Patients Planned for Percutaneous Coronary Intervention (PCI)

NCT01347580, Phase 4, Completed, AstraZeneca; results first posted 2015-02-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A 30 Day Study to Evaluate Efficacy and Safety of Pre-hospital vs. In-hospital Initiation of Ticagrelor Therapy in STEMI Patients Planned for Percutaneous Coronary Intervention (PCI). Trials, record NCT01347580. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01347580

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A 30 Day Study to Evaluate Efficacy and Safety of Pre-hospital vs. In-hospital Initiation of Ticagrelor Therapy in STEMI Patients Planned for Percutaneous Coronary Intervention (PCI)
NCT number: NCT01347580
Status: Completed
Phases: Phase 4
Enrollment: 1,875 participants, actual
Lead sponsor: AstraZeneca
Conditions: Myocardial Infarction, Segment Elevation Myocardial Infarction (STEMI)
Interventions: Ticagrelor, Placebo
First posted: 2011-05-04
Last updated: 2015-07-22
Results first posted: 2015-02-11
Limitations and caveats: This urgent setting study included 8.6% of patients with symptoms of MI in ambulance but having finally not a STEMI diagnosis in cathlab.~No prespecified hypothesis and procedure for adjustment was made on secondary endpoints.

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3 of MI Culprit Vessel at Initial Angiography (Co-primary Endpoint)	At initial angiography, pre PCI	(TIMI) flow grade classification is used to assess coronary blood flow in acute coronary syndromes. grade 0:no reperfusion, grade 1: penetration without perfusion, grade 2: Partial reperfusion, grade 3: complete perfusion.
Primary	ST-segment Elevation Resolution Pre PCI ≥70% (Co-primary Endpoint)	Between baseline and PCI	ST segment elevation resolution is the mean ST elevation pre-hospital minus the mean STelevation pre-PCI divided by the mean ST elevation pre-hospital. It is expressed as a percentage and split in 2 categories , complete (≥70%) versus incomplete (\<70%) resolution.
Secondary	1st Composite Clinical Endpoint	during the 30 days of treatment	death/MI/stroke/urgent revascularization/stent thrombosis. Adjudicated events except death
Secondary	2nd Composite Clinical Endpoint	within 30 days of study	Death/MI/urgent revascularization. Adjudicated events except death
Secondary	Definite Stent Thrombosis	during 30 days of treatment	Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. It is an adjudicated endpoint
Secondary	TIMI Flow Grade 3 Post -PCI	at coroangiography post-PCI	TIMI) flow grade 3 is complete perfusion post-PCI.
Secondary	ST Segment Elevation Resolution Post-PCI >= 70%	Between baseline and ECG 60 mn post-PCI	ST segment elevation resolution post PCI \>=70% is defined as complete resolution
Secondary	Thrombotic Bail-out With GPIIb/IIIa Inhibitors at Initial PCI	during PCI	Glycoprotein (GP) IIb/IIIa inhibitors are often used as a rescue or bailout therapy to manage complications arising during percutaneous coronary intervention.
Secondary	Major Bleeds Within 48 Hours	within 48 hours of first dose	non CABG related bleeds, (PLATO definition) include Life threatening and other major bleeds
Secondary	Minor and Major Bleedings Within 48 Hours	within 48 hours of first dose	non CABG related bleeds (PLATO definition)

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3 of MI Culprit Vessel at Initial Angiography (Co-primary Endpoint)	At initial angiography, pre PCI	mITT, on patients with non missing values	patients	NUMBER
PRIMARY	ST-segment Elevation Resolution Pre PCI ≥70% (Co-primary Endpoint)	Between baseline and PCI	mITT, on patients with non missing values	patients	NUMBER
SECONDARY	1st Composite Clinical Endpoint	during the 30 days of treatment	mITT	patients	NUMBER
SECONDARY	2nd Composite Clinical Endpoint	within 30 days of study	mITT	patients	NUMBER
SECONDARY	Definite Stent Thrombosis	during 30 days of treatment	mITT	patients	NUMBER
SECONDARY	TIMI Flow Grade 3 Post -PCI	at coroangiography post-PCI	mITT, on patients with non missing TIMI flow grade values	patients	NUMBER
SECONDARY	ST Segment Elevation Resolution Post-PCI >= 70%	Between baseline and ECG 60 mn post-PCI	mITT on patients with non missing ECG values	patients	NUMBER
SECONDARY	Thrombotic Bail-out With GPIIb/IIIa Inhibitors at Initial PCI	during PCI	mITT	patients	NUMBER
SECONDARY	Major Bleeds Within 48 Hours	within 48 hours of first dose	Safety	patients	NUMBER
SECONDARY	Minor and Major Bleedings Within 48 Hours	within 48 hours of first dose	Safety	patients	NUMBER

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3 of MI Culprit Vessel at Initial Angiography (Co-primary Endpoint)	Pre-hospital Ticagrelor	143	patients
Thrombolysis In Myocardial Infarction (TIMI) Flow Grade 3 of MI Culprit Vessel at Initial Angiography (Co-primary Endpoint)	In-hospital Ticagrelor	145	patients
ST-segment Elevation Resolution Pre PCI ≥70% (Co-primary Endpoint)	Pre-hospital Ticagrelor	102	patients
ST-segment Elevation Resolution Pre PCI ≥70% (Co-primary Endpoint)	In-hospital Ticagrelor	102	patients
1st Composite Clinical Endpoint	Pre-hospital Ticagrelor	41	patients
1st Composite Clinical Endpoint	In-hospital Ticagrelor	42	patients
2nd Composite Clinical Endpoint	Pre-hospital Ticagrelor	39	patients
2nd Composite Clinical Endpoint	In-hospital Ticagrelor	34	patients
Definite Stent Thrombosis	Pre-hospital Ticagrelor	2	patients
Definite Stent Thrombosis	In-hospital Ticagrelor	11	patients

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Pre-hospital Ticagrelor	909
Overall Study	STARTED	In-hospital Ticagrelor	953
Overall Study	Modified Intent to Treat Population	Pre-hospital Ticagrelor	906
Overall Study	Modified Intent to Treat Population	In-hospital Ticagrelor	952
Overall Study	Safety Population	Pre-hospital Ticagrelor	908
Overall Study	Safety Population	In-hospital Ticagrelor	950
Overall Study	COMPLETED	Pre-hospital Ticagrelor	844
Overall Study	COMPLETED	In-hospital Ticagrelor	897
Overall Study	NOT COMPLETED	Pre-hospital Ticagrelor	65
Overall Study	NOT COMPLETED	In-hospital Ticagrelor	56

Source ClinicalTrials.gov

Adverse events306

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Ventricular tachycardia	Cardiac disorders	Ticagrelor In-Hosp	81	950
other	Ventricular tachycardia	Cardiac disorders	Ticagrelor Pre-Hosp	79	908
other	Dyspnoea	Gastrointestinal disorders	Ticagrelor In-Hosp	86	950
other	Dyspnoea	Gastrointestinal disorders	Ticagrelor Pre-Hosp	62	908
other	Nausea	Gastrointestinal disorders	Ticagrelor In-Hosp	49	950
other	Nausea	Gastrointestinal disorders	Ticagrelor Pre-Hosp	41	908
other	Non cardiac chest pain	General disorders	Ticagrelor In-Hosp	52	950
other	Non cardiac chest pain	General disorders	Ticagrelor Pre-Hosp	42	908
other	Hypotension	Vascular disorders	Ticagrelor In-Hosp	30	950
other	Hypotension	Vascular disorders	Ticagrelor Pre-Hosp	44	908

1 to 10 of 306Source ClinicalTrials.gov

See all 306 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ticagrelor In-Hosp
Total, all-cause mortality	Ticagrelor Pre-Hosp
Total, other adverse events	Ticagrelor In-Hosp	529	950
Total, other adverse events	Ticagrelor Pre-Hosp	469	908
Total, serious adverse events	Ticagrelor In-Hosp	143	950
Total, serious adverse events	Ticagrelor Pre-Hosp	140	908

Source ClinicalTrials.gov

Papers11

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
23537967	DERIVED	PubMed
25175921	RESULT	PubMed
26952907	DERIVED	PubMed
27196998	DERIVED	PubMed
27666002	DERIVED	PubMed
28622941	DERIVED	PubMed
28939567	DERIVED	PubMed
29421001	DERIVED	PubMed
29421015	DERIVED	PubMed
30302940	DERIVED	PubMed

1 to 10 of 11

See all 11 papers

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Ticagrelor In-Hosp vs Ticagrelor Pre-Hosp: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01347580

GET https://conductscience.org/api/trials/v1/NCT01347580/results?page=2

API reference For AI assistants